ALL ORTHOPEDI APPLIANCES UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-03-02 for ALL ORTHOPEDI APPLIANCES UNKNOWN manufactured by Kirshner Medical Corporation.

Event Text Entries

[17177329] Patient placed in posey vest and soft wrist restraints. Patient found by nurse in cortorted position between bed and siderails without pulse or respirations. Patient had do not resuscitate order on chart due to terminal status. Medical examiner notified and determined cause of death to be positional aphyxiadevice not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device not used as labeled/indended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, other, other, invalid data. Results of evaluation: invalid data, invalid data, invalid data, invalid data. Conclusion: invalid data, device failed during assembly. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: invalid data. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number317
MDR Report Key317
Date Received1992-03-02
Date of Event1992-02-05
Date Facility Aware1992-02-05
Date Reported to Mfgr1992-02-21
Date Added to Maude1992-04-16
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameALL ORTHOPEDI APPLIANCES
Generic NamePOSEY VEST RESTRAINT
Product CodeBRT
Date Received1992-03-02
Model NumberUNKNOWN
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
ID NumberUNKNOWN
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityN
Implant FlagN
Device Sequence No1
Device Event Key312
ManufacturerKIRSHNER MEDICAL CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
101. Death 1992-03-02

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