UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-30 for UNKNOWN manufactured by Unknown.

Event Text Entries

[15743585] At 8:15 p. M. On july 13, 1992, resident was found on the floor of room 419. Side rail away from foot of bed. Cnastates siderail was up and latched when cna left room. This was confirmed by a visitor in the room. Resident sustained fx. Of l. Hip and was transferred. Siderail was evaluated by maintenance and found to have a broken off bolt on brace of siderail which secures brace on bed frameinvalid 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: none or unknown, other. Conclusion: device failure occurred but not related to event. Certainty of device as cause of or contributor to event: no. Corrective actions: device permanently removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1289
• MDR Report Key: 1289
• Date Received: 1992-07-30
• Date of Report: 1992-07-22
• Date of Event: 1992-07-13
• Date Facility Aware: 1992-07-13
• Report Date: 1992-07-22
• Date Reported to FDA: 1992-07-22
• Date Added to Maude: 1992-09-14
• 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: UNKNOWN
• Generic Name: BED SIDERAIL
• Product Code: FNK
• Date Received: 1992-07-30
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 1234
• Manufacturer: UNKNOWN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-30