HI-LO BED 220

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-23 for HI-LO BED 220 manufactured by Huntco.

Event Text Entries

[21583808] Resident was in her bed receiving nursing care by lpn charge nurse. The nurse adjusted the bed height moving the stablizer legs off the floor. She proceeded to give nursing care. Stablizer leg dragged on her left foot a contusion injury to her great toe. Incident investigated. The cause of the malfunction was that a pin holding the under carriage bar for the stablizer leg came out. Problem reported to vendor, to manufacturer. Beds purchased in 1990. Manufacturer will send new pins to be installed. All beds checked for this potential safety probleminvalid data - regarding single use labeling of device. 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: component failure. 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. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2490
• MDR Report Key: 2490
• Date Received: 1993-02-23
• Date of Report: 1993-02-04
• Date of Event: 1993-01-30
• Date Facility Aware: 1993-01-30
• Report Date: 1993-02-04
• Date Reported to FDA: 1993-02-04
• Date Reported to Mfgr: 1993-02-01
• Date Added to Maude: 1993-03-10
• 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: HI-LO BED
• Generic Name: PREMIERE LINE BED- UNDER CARRIAGE
• Product Code: FNK
• Date Received: 1993-02-23
• Model Number: 220
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 2315
• Manufacturer: HUNTCO

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-02-23