HILL-ROM 850F55 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 1993-01-29 for HILL-ROM 850F55 N/A manufactured by Hill-rom.

Event Text Entries

[1778] Found patient's head wedged inside siderail between the bars. The center bar had to be cut away with a hack saw to free the patient. The patient was a 93 year old female and had abrasions and bruises to the forehead and face. Attached are simulated photographs of the incident and also a copy of the letter that was sent to hill-romdevice not 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: 01-jul-92. Service provided by: user facility biomedical/bioengineering department. Service records available. 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: invalid data. Conclusion: device failure occurred and was related to event, device failure related to patient condition, device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service, other. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2341
• MDR Report Key: 2341
• Date Received: 1993-01-29
• Date of Report: 1993-01-11
• Date of Event: 1992-12-16
• Date Facility Aware: 1992-12-16
• Report Date: 1993-01-11
• Date Reported to FDA: 1993-01-11
• Date Reported to Mfgr: 1992-12-22
• Date Added to Maude: 1993-02-05
• 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: CENTRA SERIES
• Product Code: FNK
• Date Received: 1993-01-29
• Model Number: 850F55
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: HOSPITAL ID # 000911
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-JUL-92
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2167
• Manufacturer: HILL-ROM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-01-29