THE HILL ROM COMPANY 425 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 1993-02-08 for THE HILL ROM COMPANY 425 N/A manufactured by The Hill Rom Company.

Event Text Entries

[20429813] Based on physician orders for side rails, patient's bed had the rails up. At 11:05 p. M. On 7/14/92 patient was found by the on-duty nurse with her head, shoulder, throat and one arm between the side rail and the bed in the middle of the left side of the bed. When discovered, patient had no vital signs. She was still warm to the touch, her skin was mildly white and there was no petechiae or bloating of the face. The coronor's report is attacheddevice labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced:. Service provided by: manufacturer. Service records available. 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: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: device permanently 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: 3432
• MDR Report Key: 3432
• Date Received: 1993-02-08
• Date of Report: 1992-12-28
• Date of Event: 1992-07-14
• Date Facility Aware: 1992-07-14
• Report Date: 1992-12-28
• Date Reported to Mfgr: 1992-07-24
• Date Added to Maude: 1993-04-20
• 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: THE HILL ROM COMPANY
• Generic Name: HOSPITAL BED - SPLIT RAILS
• Product Code: FNK
• Date Received: 1993-02-08
• Model Number: 425
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER
• Device Availability: Y
• Device Age: 01-JUL-89
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3192
• Manufacturer: THE HILL ROM COMPANY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1993-02-08