VEST TYPE RESTRAINT 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 1993-01-05 for VEST TYPE RESTRAINT N/A manufactured by Skil-care Corporation.

Event Text Entries

[20054804] Patient was placed in wheelchair at 10:15 pm with vest type restraint in place by two (2) cna(s) while changing her bed. The cna(s) left the room for a short time. At 10:30 pm cna returned to put patient back to bed and found patient sitting in floor in front of wheelchair with restraint still tied. The charge nurse responded to the emergency. Patient gotten onto bed and cpr started immediately. Ambulance service called and continued with cpr until and during transfer to hospital. The nursing home was advised later by the hospital that patient was pronounced dead at 12:12 amdevice 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 used as labeled/intended. Device was evaluated after the event. Method of evaluation: a device from same lot was evaluated, visual examination. Results of evaluation: design - inadequate. Conclusion: other. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service, inserviced by other facility staff. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2012
• MDR Report Key: 2012
• Date Received: 1993-01-05
• Date of Report: 1992-12-18
• Date of Event: 1992-12-13
• Date Facility Aware: 1992-12-13
• Report Date: 1992-12-18
• Date Reported to FDA: 1992-12-18
• Date Reported to Mfgr: 1992-12-18
• Date Added to Maude: 1993-01-06
• 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: VEST TYPE RESTRAINT
• Generic Name: N/A
• Product Code: BRT
• Date Received: 1993-01-05
• Model Number: N/A
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: N/A
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1869
• Manufacturer: SKIL-CARE CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1993-01-05