{"id":"b52058bb-f0e0-4917-944d-daf2e6a25ae3","slug":"vocera-badge-alarm-auto-acknowledge-2019","kind":"malfunction","headline":"Vocera Badge auto-acknowledged second critical alarm notification when two arrived within seconds, leaving nurse unaware of second patient's desaturation","summary":"Two patients cared for by the same nurse had critical desaturations within seconds of one another. The monitoring system routed alarm notifications for both patients to the same Vocera badge, but the badge did not enunciate the second notification or require a separate acknowledgement. When the nurse acknowledged the first alarm, the second was automatically cancelled. A passing staff member heard the room alarm and responded, preventing patient harm. Vocera validated the issue. The event was recreated by pulling two code blue buttons simultaneously.","occurredAt":"2019-04-22T00:00:00.000Z","reviewStatus":"unreviewed","modelId":"7dfdb7e9-be06-4c56-a06e-674f45d0f970","deploymentId":null,"companyId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"moderate","rootCauseCategory":"software_defect","rootCauseDetail":"Software defect in alarm notification delivery: when multiple alarm notifications arrive at the same badge within seconds, the system auto-acknowledges subsequent alarms when the first is acknowledged, rather than requiring separate acknowledgement for each.","affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":"acknowledged","regulatoryAction":"none","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":null,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-07-30T11:03:21.918Z","updatedAt":"2026-07-30T11:03:21.918Z","model":{"id":"7dfdb7e9-be06-4c56-a06e-674f45d0f970","companyId":"af06508b-0fe6-44d0-9200-7566963ae824","modelName":"Vocera Badge","slug":"vocera-badge","description":"A hands-free, wearable, voice-activated Wi-Fi communication device for healthcare environments. Connects clinicians by name, role, or group broadcast, enabling instant communication without pagers or phones. First shipped in 2002 as the B1000 model.","formFactor":"other","industryVertical":null,"environment":null,"maturityStage":"production","lifecycleState":"active","supersededByModelId":null,"specs":{},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://vocera.stryker.com/s/product-hub/vocera-badge?language=en_US","label":"Vocera Badge","title":"Vocera Badge","mediaType":"article","sourceName":"Vocera (Stryker)"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[],"createdAt":"2026-07-30T11:03:04.683Z","updatedAt":"2026-07-30T11:03:56.877Z","unitsInFieldClaimed":null,"unitsInFieldVerified":null,"unitsManufacturedClaimed":null,"unitsManufacturedVerified":null,"unitsAsOf":null,"unitsSource":null,"salesModel":null,"priceUndisclosedSince":null,"autonomyClass":null,"autonomyStatement":null,"autonomyStatementSource":null,"demoForensics":null,"exportControlClass":null,"minCommitment":null,"warrantyTerms":null,"serviceModel":null,"productionRateClaimed":null,"productionRateEvidenced":null,"teleopRatioDisclosed":null,"interventionRateDisclosed":null},"deployment":null,"company":null,"derived":{"status":"active"},"sources":[{"id":"6d25b780-5699-4594-aa20-d182b6aea54d","incidentId":"b52058bb-f0e0-4917-944d-daf2e6a25ae3","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8591239&pc=MSX","label":"FDA MAUDE","publishedAt":"2019-05-03T00:00:00.000Z","notes":null,"title":null,"sourceName":"FDA MAUDE","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-30T11:03:21.918Z","updatedAt":"2026-07-30T11:03:21.918Z"}],"responses":[],"statusEvents":[{"id":"0fd439b0-4a8c-4f73-b268-84e2549ca838","incidentId":"b52058bb-f0e0-4917-944d-daf2e6a25ae3","status":"active","reason":null,"source":"agent:recon","effectiveAt":"2026-07-30T11:03:23.028Z","createdAt":"2026-07-30T11:03:23.028Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/vocera-badge-alarm-auto-acknowledge-2019","url":"https://registry.deploy.report/incidents/vocera-badge-alarm-auto-acknowledge-2019","headline":"Vocera Badge auto-acknowledged second critical alarm notification when two arrived within seconds, leaving nurse unaware of second patient's desaturation","description":"Two patients cared for by the same nurse had critical desaturations within seconds of one another. The monitoring system routed alarm notifications for both patients to the same Vocera badge, but the badge did not enunciate the second notification or require a separate acknowledgement. When the nurse acknowledged the first alarm, the second was automatically cancelled. A passing staff member heard the room alarm and responded, preventing patient harm. Vocera validated the issue. The event was recreated by pulling two code blue buttons simultaneously.","identifier":"b52058bb-f0e0-4917-944d-daf2e6a25ae3","datePublished":"2019-04-22T00:00:00.000Z","articleSection":"malfunction","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"unreviewed","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":1,"primary_source_types":["primary-fda-database"]}}}