HOSPITAL BED T7017GLI-PL53860 UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-20 for HOSPITAL BED T7017GLI-PL53860 UNKNOWN manufactured by Inter-royal.

Event Text Entries

[19145640] The incident occurred on 7/5/92. A female patient age 63 was allegedly found with her head caught between bed rails and bed. We believe a probability exists that the medical device may have contributed to her deathinvalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. Invalid data - regarding 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. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1089
• MDR Report Key: 1089
• Date Received: 1992-07-20
• Date of Report: 1992-07-10
• Date of Event: 1992-07-05
• Date Facility Aware: 1992-07-10
• Report Date: 1992-07-10
• Date Reported to FDA: 1992-07-10
• Date Reported to Mfgr: 1992-07-10
• Date Added to Maude: 1992-08-20
• 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: HOSPITAL BED
• Generic Name: BED
• Product Code: FNK
• Date Received: 1992-07-20
• Model Number: T7017GLI-PL53860
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 1043
• Manufacturer: INTER-ROYAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1992-07-20