852 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 1992-07-03 for 852 N/A manufactured by Hill-rom.

Event Text Entries

[2398] Patient found in floor after nurse lowered position. Apparant cause was failure of rail to lock into upright position. Patient suffered broken hip as a resultdevice 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: other. Conclusion: device failure occurred and was related to event, other. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3216
• MDR Report Key: 3216
• Date Received: 1992-07-03
• Date of Report: 1991-12-23
• Report Date: 1991-12-23
• Date Added to Maude: 1993-04-13
• 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

• Product Code: FNK
• Date Received: 1992-07-03
• Model Number: 852
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER
• Device Availability: Y
• Device Age: 01-AUG-88
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3000
• Manufacturer: HILL-ROM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-03