MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-01-15 for manufactured by .

Event Text Entries

[15489988] On 11/7/97, a morbidly obese (300 pound) 30 y/o woman, who was mildly retarded, freed at least one of her hands from her restraints. This pt then self extubated, which caused her to go into cardiac arrest. She was laying in vivax medical corp's ("vivax") novabed with head and foot sections of bed in raised position when this event occurred. Nurse who first responded to this code situation pressed head and foot down buttons on novabed pendant, which is located at head of bed, to lower head and foot sections of bed. Nurse took this action so that "cpr" could be performed on this pt when she was in a horizontal position. This action, however, did not lower head and foot sections of bed because bed motor on/off switch had not been placed in "on" position. Bed power motor switch must be in "on" position (hereinafter "bed motor is on") to lower these sections of bed. Nurse then looked at control panel of bed, which is located at foot of bed. According to nurse, control panel displayed message "check c. P. Cable. " this message is displayed only when bed motor power is off because buttons on control panel or bed pendant have not been pushed for at least five minutes. Therefore, this message indicates that power is being supplied to bed but bed motor is not on. A red light on control is illuminated when bed motor is on. Nurse then attempted to turn bed motor on but she did not do so either because she turned bed motor on and then off again in rapid succession or she pushed another button that put bed in "standby" or "lockout" mode. These two modes are only modes in which head and/or foot sections of bed cannot be lowered using bed pendant when head of bed is attached and bed motor power is on. Nurse then pressed head and foot down buttons. These sections still did not lower because either bed motor was not on or bed was in "standby" or "lockout" modes. Nurse did not notice whether red motor bed light was illuminated. Nurse pulled cpr release tag on air mattress, which deflated this mattress. Air mattress was mfg by a company other than vivax. This air mattress's cpr release tag was not intended to and, thus, did not lower head or foot sections of novabed since this mattress is not an integrated component of bed. Novabed has a manual latch for lowering head and foot sections of bed in event of power failure or when no electricity is being supplied to bed. Attendants did not attempt to lower head and foot sections of this pt's bed by using manual latch. A physician then ordered that pt be moved to another bed so that she could be placed in a horizontal position in order for cpr to be performed on her. Hospital team transferred her to another bed, which was not a novabed. Team performed cpr on this pt but they were unable to resuscitate her. She died in other bed. Distributor, is presence of hospital staff, tested novabed in which pt was originally laying on site immediately after event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1224873-1998-00001
MDR Report Key144615
Report Source06
Date Received1998-01-15
Date of Event1997-11-07
Date Mfgr Received1997-12-29
Device Manufacturer Date1996-05-01
Date Added to Maude1998-01-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location0
Single Use3
Remedial ActionMA
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Product CodeFRZ
Date Received1998-01-15
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key140996
Baseline Brand NameVIVAX MOBILITY SYSTEM
Baseline Generic NamePATIENT TRANSFER SYSTEM
Baseline Model NoNOVA BED
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilyVIVAX MOBILITY SYSTEMS
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK964246
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 1998-01-15

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