BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOALTE NURSE CALL

    MDR report key: 19112975 · Received April 15, 2024

    Report

    Report Number
    2027454-2024-00026
    Event Type
    Death
    Date Received
    April 15, 2024
    Date of Event
    March 21, 2024
    Report Date
    April 15, 2024
    Manufacturer
    HILL-ROM CARY
    Product Code
    ILQ
    UDI-DI
    00887761995079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. THE PATIENT IN THIS EVENT WAS A 76-YEAR-OLD MALE WITH AN ADMITTING DIAGNOSIS OF LEFT RIB FRACTURES 7-10 AND MEDICAL HISTORY OF END STAGE RENAL DISEASE, DIABETES, HYPERTENSION, HYPERLIPIDEMIA, CORONARY ARTERY DISEASE, CONGESTIVE HEART FAILURE, AND CHRONIC RESPIRATORY FAILURE. MEDICAL TREATMENT FOR THE EVENT INCLUDED RESUSCITATION. A CT SCAN SHOWED THE FOLLOWING: SOFT TISSUE HEMATOMA IN RIGHT FRONTAL LOCATION, THERE IS A SMALL AMOUNT OF PARENCHYMAL HEMORRHAGE IN THE RIGHT FRONTAL LOBE, THE ACUTE POSTTRAUMATIC CHANGES ARE SUPERIMPOSED ON EXTENSIVE CORTICAL ATROPHY MARKEDLY ADVANCED FOR AGE; COMMINUTED FRACTURE OF THE DENS WITH MILD ANTEROLISTHESES OF THE INFERIOR ASPECT OF THE BODY OF C2 VERSUS THE TIP OF THE DENS BY NEARLY 6MM; THERE IS A COMMINUTED FRACTURE OF THE ANTERIOR RING OF C1 BOTH ANTERIORLY AND POSTERIORLY AS WELL AS OF THE POSTERIOR RING; BIFFL GRADE 3 VASCULAR INJURY OF THE RIGHT VERTEBRAL ARTERY AT THE V3-V4 JUNCTION; BIFFL GRADE 1 VERSUS GRADE 2 VASCULAR INJURY OF THE LEFT VERTEBRAL ARTERY AT THE V2-V3 JUNCTION; NONDISPLACED HAIRLINE FRACTURE OF THE RIGHT FRONTAL CALVARIUM EXTENDING INTO THE SUPERIOR WALL OF THE RIGHT ORBIT; ACUTE DEPRESSED FRACTURE OF THE SUPERIOR WALL OF THE RIGHT ORBIT WITH EXTRACONAL STRANDING IN THE SUPEROLATERAL QUADRANT; SUSPECTED FRACTURE OF THE POSTEROLATERAL WALL OF THE RIGHT MAXILLARY SINUS WITH ASSOCIATED HEMOSINUS. MRI SHOWED THE FOLLOWING: UNSTABLE CERVICAL SPINE FRACTURE-DISLOCATION INVOLVING C1/C2 AND THE ATLANTOAXIAL JOINTS, WITH MULTIPLE ASSOCIATED LIGAMENTOUS INJURIES; SPINAL CORD CONTUSION AT C1-C2; SUBTLE ASYMMETRICAL WIDENING OF THE RIGHT C2-C3 FACET JOINT. THE PATIENT DIED ON (B)(6) 2024 AT 18:43. THE CAUSE OF DEATH WAS REPORTED AS RESPIRATORY FAILURE AND CERVICAL FRACTURE. AT THE TIME OF THE REPORTED INCIDENT, THE PATIENT WAS ON A VERSACARE BED (SERIAL NUMBER UNKNOWN) AND AN ASBC AND BREAKAWAY (COMMUNICATION) CABLE WAS IN USE. PER THE PATIENT¿S NURSE, THE BED EXIT WAS ARMED, BUT ALLEGEDLY DID NOT ALARM AT THE BED. THE CUSTOMER STATED IT WAS ASSUMED THAT THE BED SHOWED OFFLINE/NOT CONNECTED AT THE NURSE'S STATION. NO ADDITIONAL INFORMATION WAS REPORTED BY THE CUSTOMER. THE VOALTE NURSE CALL SYSTEM PROVIDES A COMPREHENSIVE COMMUNICATION AND INFORMATION SYSTEM THAT PLACES PATIENT CALLS, STAFF CALLS AS WELL AS EMERGENCY AND CODE CALLS. THE SYSTEM OFFERS SEVERAL CALLING OPTIONS DEPENDING ON THE CONFIGURATION OF THE FACILITY. TROUBLESHOOTING ACTIVITIES PERFORMED BY BAXTER CONFIRMED THE BED WAS NOT CONNECTED TO NURSE CALL AT THE TIME OF THE ALLEGED EVENT. A REVIEW OF THE NURSE CALL BED DATA REPORT FOR ROOM 361 SUPPORTS THAT NURSE CALL AND PATIENT SAFETY WERE OPERATING CORRECTLY PRIOR TO THE REPORTED EVENT AS BED EXIT EVENTS WERE OCCURRING AS EXPECTED. FURTHER REVIEW FOUND THE PREVIOUS PATIENT WAS DISCHARGED FROM THE BED ON (B)(6) 2024 AT APPROXIMATELY 17:30. DATA POINTS OVER THE NEXT APPROXIMATELY 2.5 HOURS SUGGEST HOUSEKEEPING WAS CLEANING THE ROOM DURING WHICH TIME THE BED WAS DISCONNECTED FROM NURSE CALL AND A BED DISCONNECT ALERT DISPLAYED AND WAS IMMEDIATELY CANCELLED AT APPROXIMATELY 20:00. THE BED WAS NEVER RECONNECTED TO NURSE CALL. ON (B)(6)2024 AT 20:45, THE PATIENT IN THE REPORTED EVENT WAS ADMITTED TO THE BED. A BED OFFLINE STATUS WAS NOTED ON THE BED DATA REPORT, WHICH WOULD DISPLAY ON CAREGIVER INTERFACES (GRS5 IN PATIENT ROOM AND STATUS BOARD). THE LOST ASBC CALL MENTIONED BY THE CUSTOMER WAS NOTED TO HAVE OCCURRED ON (B)(6) 2024 AT 0:36, AFTER THE REPORTED EVENT, AND CANCELED THE SAME DAY AT 19:13. THE BED DATA REPORT SHOWED NO NURSE CALL HARDWARE ISSUES OCCURRING IN ROOM 361 IN THE SEVEN DAYS LEADING UP TO THE ALLEGED EVENT; THEREFORE, IT CAN BE CONCLUDED THAT THE LOST ASBC CALL WAS UNRELATED TO THE ALLEGED EVENT. IN THIS EVENT, IT WAS ALLEGED THAT THE BED EXIT DID NOT ALARM THROUGH THE VOALTE NURSE CALL SYSTEM AND A PATIENT FELL AND SUBSEQUENTLY DIED. TROUBLESHOOTING ACTIVITIES PERFORMED BY BAXTER FOUND NO NURSE CALL HARDWARE ISSUES FOR THE ROOM WHERE THE REPORTED INCIDENT OCCURRED IN THE DAYS LEADING UP TO THE INCIDENT; HOWEVER, THE BED BECAME DISCONNECTED FROM THE NURSE CALL SYSTEM, POSSIBLY WHILE HOUSEKEEPING WAS CLEANING THE BED AND PRIOR TO THE PATIENT BEING ADMITTED TO THE BED. A BED DISCONNECT ALERT PROPERLY DISPLAYED ON THE NURSE CALL SYSTEM AND WAS IMMEDIATELY CANCELED BY THE USER. A BED OFFLINE STATUS WAS NOTED AS EXPECTED WHEN THE PATIENT WAS ADMITTED TO THE BED, AND CAREGIVERS WOULD BE ALERTED OF THIS STATUS VIA GRS5 AND STATUS BOARD. THE CAUSE OF THE REPORTED EVENT CAN BE CONTRIBUTED TO USE ERROR (BED DISCONNECTED FROM NURSE CALL AND NOT RECONNECTED).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE NO SYSTEM ALERTS OR BED EXIT ALARM ON THE VOALTE NURSE CALL SYSTEM AND A PATIENT THAT WAS IDENTIFIED AS A FALLS RISK REPORTEDLY FELL AND SUBSEQUENTLY DIED. ON (B)(6) 2024, NURSING STAFF FOUND THE PATIENT DOWN IN ROOM 361 AND PLACED A CODE BLUE CALL AT 00:25 AND THE CODE CALL FUNCTIONED CORRECTLY. AS PART OF THE CUSTOMER¿S INTERNAL INVESTIGATION, A BED DATA REPORT WAS REVIEWED, AND THE BED SHOWED OFFLINE AT THE TIME OF THE INCIDENT. PER THE CUSTOMER, A LOST ASBC CALL OCCURRED ON (B)(6)2024, AND THE CUSTOMER CHANGED OUT A DAMAGED ASBC ON (B)(6) 2024. THE CUSTOMER REQUESTED TROUBLESHOOTING ASSISTANCE FROM BAXTER TO GATHER MORE SPECIFIC DATA TO DETERMINE WHEN THE BED WENT OFFLINE. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125629 VOALTE NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM CARY 00887761995079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown