RECYCLED JACKET 3138 3138 MED

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-06-09 for RECYCLED JACKET 3138 3138 MED manufactured by J.t. Posey.

Event Text Entries

[389] Patient tried to get out of bed, was restrained by posey and became entangled in posey and bed siderail. Bed siderail and posey both restricted patient's ability to breath; thus, patient arrested, and subsequently expired two weeks later. As a result of our evaluation, consideration will be given to additional monitoring of restrained patients. Relevant device: hill-rom co. , inc. - centra retractable bedevice not labeled for single use. Patient medical status prior to event: satisfactory 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 used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, other, other. Results of evaluation: other. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number672
MDR Report Key672
Date Received1992-06-09
Date of Report1992-05-27
Date of Event1992-05-02
Date Facility Aware1992-05-02
Report Date1992-05-27
Date Reported to FDA1992-05-27
Date Reported to Mfgr1992-05-27
Date Added to Maude1992-06-10
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 NameRECYCLED JACKET
Generic NamePOSEY JACKET
Product CodeBRT
Date Received1992-06-09
Model Number3138
Catalog Number3138 MED
Lot NumberN/A
ID NumberN/A
OperatorOTHER
Device AvailabilityY
Implant FlagN
Device Sequence No1
Device Event Key659
ManufacturerJ.T. POSEY


Patients

Patient NumberTreatmentOutcomeDate
101. Death 1992-06-09

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