CENTURY MODEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for CENTURY MODEL manufactured by Hill-rom.

Event Text Entries

[2901] During emergency transfer of patient from micu to radiology, a shock absorber was discovered hanging down from the patient's right side of the bed (head section). The emergency transfer and ct scan was delayed by the need to transfer the patient to a bed in operting condition. The shock absorber was discovered to be hanging down with a broken post still connecteddevice not labeled for single use. Patient medical status prior to event: critical 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. 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, a device from same lot was evaluated, mechanical tests performed, performance tests performed, visual examination. Results of evaluation: inadequate quality assurance, failure to service/maintain according to manufacturer recomm. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service, none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4662
• MDR Report Key: 4662
• Date Received: 1992-07-31
• Date of Report: 1992-02-14
• Date of Event: 1992-01-30
• Date Facility Aware: 1992-01-30
• Report Date: 1992-02-14
• Date Reported to Mfgr: 1992-02-14
• Date Added to Maude: 1993-06-01
• 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: CENTURY MODEL
• Generic Name: ICU BED
• Product Code: FNK
• Date Received: 1992-07-31
• ID Number: UHC PROPERTY 135809
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-MAY-88
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 4378
• Manufacturer: HILL-ROM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-31