POSEY RESTRAINT 1334

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-02-19 for POSEY RESTRAINT 1334 manufactured by J.t. Posey Company.

Event Text Entries

[61] 97 year old blind, spanish speaking, female admitted to hospital on 1/18/92 with gastroenteritis and lobar pneumonia. Hgt. 4'11"; weight 120 lbs. Had a hiostory of falling at home. Placed on fall prevention program including use of posey waist restraints. At 0002 hrs. On 1/20/92 found dead, dangling frm bed with posey intact between upper and lower siderails. All four rails up. (noted to be resting quietly in bed at 2200 hrs. ) cornor investigation concluded asphyxia due to abdominal constrictiondevice 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, visual examination. Results of evaluation: telemetry failure, none or unknown, unanticipated. Conclusion: no failure detected and product within specification. Certainty of device as cause of or contributor to event: invalid data. 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: 89
• MDR Report Key: 89
• Date Received: 1992-02-19
• Date of Report: 1992-01-30
• Date of Event: 1992-01-20
• Date Facility Aware: 1992-01-20
• Report Date: 1992-01-30
• Date Reported to FDA: 1992-01-30
• Date Reported to Mfgr: 1992-01-30
• Date Added to Maude: 1992-03-26
• 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: POSEY RESTRAINT
• Generic Name: PATIENT RESTRAINT
• Product Code: BRT
• Date Received: 1992-02-19
• Model Number: 1334
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 87
• Manufacturer: J.T. POSEY COMPANY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1992-02-19