UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-05-29 for UNKNOWN manufactured by Unknown.

Event Text Entries

[656] A certified nurse aide placed a resident at nursing home in bed, pulling siderail did not lock into place and resident rolled out of bed. The resident suffered a dislocated shoulder from her fall. The nurse aide felt that the incident was caused by a combination of his neglience and the wear of the siderail investigation showed that the siderail did work, however not as long as it should have. Maintenance personnell made proper adjustments to the siderail for continued use. The equipment is older but in good condition. The facility has no information on the product or manufacturerinvalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced:. Service provided by: invalid data. Service records not available. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: mechanical tests performed, performance tests performed, visual examination. Results of evaluation: none or unknown, none or unknown, failure to follow instructions. Conclusion: device failure indirectly contributed to event. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device repaired and put back in service, inserviced by other facility staff. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number647
MDR Report Key647
Date Received1992-05-29
Date of Report1992-05-12
Date of Event1992-05-04
Date Facility Aware1992-05-04
Report Date1992-05-12
Date Reported to FDA1992-05-12
Date Added to Maude1992-06-03
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN
Generic NameBED SIDE RAILS
Product CodeFNK
Date Received1992-05-29
Model NumberUNKNOWN
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
ID NumberUNKNOWN
OperatorOTHER CAREGIVERS
Device AvailabilityY
Implant Flag*
Device Sequence No1
Device Event Key634
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1992-05-29

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