SAFETY VEST 3331 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-09-22 for SAFETY VEST 3331 N/A manufactured by J.t. Posey Company.

Event Text Entries

[718] Resident found at bedside with posey vest restraint belt wrapped around her neck. Was transferred to the hospital and pronounced dead. Incident called into michigan department of public health ( complaint # a-92-0884)and attorney generals officeinvalid data - regarding single use labeling of device. 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 used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: storage/shipment, failure to follow instructions, incorrect technique/procedure, misapplication of device. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: yes. Corrective actions: user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1412
• MDR Report Key: 1412
• Date Received: 1992-09-22
• Date of Report: 1992-09-09
• Date of Event: 1992-06-16
• Date Facility Aware: 1992-06-16
• Report Date: 1992-09-09
• Date Reported to FDA: 1992-09-09
• Date Added to Maude: 1992-09-29
• 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: SAFETY VEST
• Generic Name: POSEY RESTRAINT
• Product Code: BRT
• Date Received: 1992-09-22
• Model Number: 3331
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER CAREGIVERS
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1355
• Manufacturer: J.T. POSEY COMPANY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1992-09-22