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 N/A manufactured by Joerns Furniture Company.

Event Text Entries

[2473] Resident slipped between siderail and matress. Death by suffocation due to being wedged between siderail and matressinvalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device not serviced in accordance with service schedule. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. 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: design - inadequate. Conclusion: intermittent failure directly caused event, device failure directly contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2510
• MDR Report Key: 2510
• Date Received: 1993-02-08
• Date of Report: 1993-01-25
• Date of Event: 1993-01-23
• Date Facility Aware: 1993-01-23
• Report Date: 1993-01-25
• Date Reported to FDA: 1993-01-25
• Date Reported to Mfgr: 1993-01-25
• 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: N/A
• Generic Name: HOSPITAL BED
• Product Code: FNK
• Date Received: 1993-02-08
• Model Number: N/A
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: N/A
• Device Availability: *
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2335
• Manufacturer: JOERNS FURNITURE COMPANY

Patients

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