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 Number: 672
• MDR Report Key: 672
• Date Received: 1992-06-09
• Date of Report: 1992-05-27
• Date of Event: 1992-05-02
• Date Facility Aware: 1992-05-02
• Report Date: 1992-05-27
• Date Reported to FDA: 1992-05-27
• Date Reported to Mfgr: 1992-05-27
• Date Added to Maude: 1992-06-10
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RECYCLED JACKET
• Generic Name: POSEY JACKET
• Product Code: BRT
• Date Received: 1992-06-09
• Model Number: 3138
• Catalog Number: 3138 MED
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 659
• Manufacturer: J.T. POSEY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1992-06-09