HILL-ROM PM-2546

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-02 for HILL-ROM PM-2546 manufactured by Centra.

Event Text Entries

[1520] While bed was in tredelenberg, patient sustained cardiac arrest. Unable to get bed out of trendelenberg so cardio-pulmonary resuscitation was initiated with patient in trendelenberg position. Maintenance called and mechanic was only able to get out of tredelenberg position manually. After patient transferred to ccu, mechanic checked bed and found trendelenberg control jammed. When the bed was raised manually, the control freed itself and the bed worked fine thereafter. Cardiac arrest not related to inability to get bed out of trendelenberg. However very difficult to perform cpr with patient in that positiondevice not labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-jan-92. Service provided by: user facility biomedical/bioengineering department. 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, mechanical tests performed. Results of evaluation: other. Conclusion: device failure directly contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3891
• MDR Report Key: 3891
• Date Received: 1993-02-02
• Date of Report: 1992-12-21
• Date of Event: 1992-08-18
• Date Facility Aware: 1992-08-18
• Report Date: 1992-12-21
• Date Reported to FDA: 1992-12-21
• Date Reported to Mfgr: 1992-08-31
• Date Added to Maude: 1993-05-07
• 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: HILL-ROM
• Generic Name: HOSPITAL BED
• Product Code: FNK
• Date Received: 1993-02-02
• Catalog Number: PM-2546
• ID Number: HOSPITAL ID# 13511
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3631
• Manufacturer: CENTRA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-02-02