FDA Adverse Event Injury Summary report: N

UNKNOWN

MDR report key: 647 · Received May 29, 1992

Report

Report Number
647
Event Type
Injury
Date Received
May 29, 1992
Date of Event
May 4, 1992
Report Date
May 12, 1992
Manufacturer
UNKNOWN
Product Code
FNK
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 UNKNOWN BED SIDE RAILS FNK UNKNOWN UNKNOWN UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 80 YR Required Intervention