FDA Adverse Event Injury Summary report: N

STRETCHER

MDR report key: 5051 · Received June 11, 1993

Report

Report Number
5051
Event Type
Injury
Date Received
June 11, 1993
Date of Event
April 16, 1993
Report Date
April 23, 1993
Manufacturer
MIDMARK
Product Code
INK
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

ON APRIL 19, 1993, A PATIENT IN OUR AMBULATORY CARE UNIT (ACU) FELL OFF A MIDMARK STRETCHER. PRIOR TO THE FALL, THE SIDE RAIL WAS IN THE UP POSITION. THE PATIENT DOES NOT KNOW HOW SHE FELL OFF THE STRETCHER. THE NURSE TAKING CARE OF HER HAD TOLD THE PATIENT THAT SHE WAS GOING TO CHANGE HER SHEETS AND SHE SAID SHE WOULD BE RIGHT BACK. THE PATIENT'S HUSBAND WALKED OUT OF THE ROOM. THE NURSE WAS IN THE PATIENT'S BATHROOM ABOUT TWENTY FEET FROM THE STRETCHER. THE NURSE HEARD A NOISE AND THE PATIENT WAS ON THE FLOOR. THE PATIENT FRACTURED HER WRIST. SHE HAD A CAST APPLIED AND THE CASZT, AS I UNDERSTAND IT, IS ABLE TO BE REMOVED APRIL 19, 1993.IMMEDIATELY FOLLOWING THE FALL, THE MAINTENANCE DEPARTMENT WAS CONTACTED TO CHECK THE STRETCHER. THE STRETCHER WAS CHECKED AND THE LATCHING DEVICE OF THE SIDERAIL WAS WORKING APPROPRIATELY. THERE WERE NO PROBLEMS IDENTIFIED. IT REMAINED A PUZZLEMENT AS TO WHAT HAPPENED THAT THE PATIENT FELL OFF THE STRETCHER WHEN THE RAIL WAS IN THE UP POSITION AND AT THE TIME OF FALL THE RAIL WAS IN THE DOWN POSITIONINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: INSERVICED BY OTHER FACILITY STAFF. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 STRETCHER INK MIDMARK 1900

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention