FDA Adverse Event Injury Summary report: N

ECONOLINE

MDR report key: 2968 · Received July 30, 1992

Report

Report Number
2968
Event Type
Injury
Date Received
July 30, 1992
Date of Event
January 8, 1992
Report Date
April 21, 1992
Manufacturer
CONTEMPORARY (OUT OF BUSINESS - LUMEX BOUGHT INVENTORY)
Product Code
IMM
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

AS THE PATIENT WAS BEING TRANSFERRED FROM THE WHEELCHAIR TO THE BED, THE FOOT REST ON THE WHEELCHAIR FELL. THE PATIENT'S LEG/FOOT CAUGHT ON THE FALLEN FOOT REST, PATIENT EXAMINATION REVEALED AN ABRASION AND DISCOLORATION ON HER RIGHT LEG AND SUBSEQUENT X-RAYS REVEALED A FRACTURE OF THE RIGHT TIBIA AND FIBULA. EVALUATION OF THE WHEELCHAIR REVEALED A LOOSE CONNECTION ON THE FOOT REST.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-DEC-91. SERVICE PROVIDED BY: OTHER. SERVICE RECORDS NOT AVAILABLE.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. RESULTS OF EVALUATION: MECHANICAL PROBLEM, TELEMETRY FAILURE, NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT, DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. 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 ECONOLINE WHEELCHAIR IMM CONTEMPORARY (OUT OF BUSINESS - LUMEX BOUGHT INVENTORY) UNKNOWN UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 81 YR Required Intervention