NI UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-06-23 for NI UNKNOWN manufactured by Ni.

Event Text Entries

[18476261] The resident fell out of bed. If the siderails were up in the correct position as stated by nursing personnel, then the siderail must have fallen prematurely while unattended, since there is a concensus that the resident is too weak to climb over the siderails. See attached supplement for device evaluation. The resident was treated for a laceration to the left temporal area of the head. Later, a ct scan revealed a "trauma to the left brain surface", as reported by the family. The resident still remains in the acute facility at this timedevice not labeled for single use. Patient medical status prior to event: fair 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, mechanical tests performed, performance tests performed, visual examination. Results of evaluation: design - inadequate, inadequate quality assurance, invalid data. Conclusion: device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: maybe. Corrective actions: user education provided, inserviced by other facility staff, none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 764
• MDR Report Key: 764
• Date Received: 1992-06-23
• Date of Report: 1992-06-04
• Date of Event: 1992-06-01
• Date Facility Aware: 1992-06-01
• Report Date: 1992-06-04
• Date Reported to FDA: 1992-06-04
• Date Added to Maude: 1992-06-25
• 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: NI
• Generic Name: MECHANICAL BED WITH SIDERAILS
• Product Code: FNK
• Date Received: 1992-06-23
• Model Number: NI
• Catalog Number: UNKNOWN
• Lot Number: NONE
• ID Number: NONE
• Operator: OTHER
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 749
• Manufacturer: NI

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-06-23