MEDISTRAINTS N/A MDT 82 - 8040

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 MEDISTRAINTS N/A MDT 82 - 8040 manufactured by Medline.

Event Text Entries

[705] The device had been used nightly (with medical authorization and for its intended use) for 18 months with no known undesirable or negative outcomes. On the night of the reported event, the patient was found with her feet and legs on the floor and her back toward the bed. The restraint vest straps were tight around her neck, with the bed's side-rail's up. Upon discovery of this situation, the staff attempted resuscitation; however, the patient had expired despite these efforts. Analysis of the event disclosed neither device failure nor user error (based on instructions provided by the manufacturer)device 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: actual device involved in incident was evaluated, visual examination. Results of evaluation: telemetry failure, none or unknown, none or unknown, inherent risk of procedure. Conclusion: no failure detected and product within specification. Certainty of device as cause of or contributor to event: yes. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 669
• MDR Report Key: 669
• Date Received: 1992-06-09
• Date of Report: 1992-05-26
• Date of Event: 1992-05-17
• Date Facility Aware: 1992-05-20
• Report Date: 1992-05-26
• Date Reported to FDA: 1992-05-26
• Date Reported to Mfgr: 1992-05-26
• 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: MEDISTRAINTS
• Generic Name: N/A
• Product Code: BRT
• Date Received: 1992-06-09
• Model Number: N/A
• Catalog Number: MDT 82 - 8040
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 656
• Manufacturer: MEDLINE

Patients

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