FDA Adverse Event Malfunction Summary report: N

WAVERLY GLEN

MDR report key: 2961546 · Received January 25, 2013

Report

Report Number
2961546
Event Type
Malfunction
Date Received
January 25, 2013
Date of Event
January 24, 2013
Report Date
January 25, 2013
Manufacturer
PRISM MEDICAL
Product Code
FSA
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MA, US

Narratives

Description of Event or Problem · 1

THE PATIENT WAS STRAPPED INTO THE CEILING LIFT BY NURSING STAFF. WHEN THE PATIENT WAS IN SLING APPROXIMATELY 8 INCHES OFF THE BED, THE METAL CARRY BAR CAME DISCONNECTED FROM THE CEILING LIFT. THE CARRY BAR DROPPED ONTO THE PATIENT'S ABDOMEN.CLINICIANS REPORTED NO HARM TO THE PATIENT.======================MANUFACTURER RESPONSE FOR CEILING LIFT, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================SERVICE PROVIDER (3RD PARTY VENDOR WHO INSPECTS/REPAIRS WAVERLY CEILING LIFTS AT OUR INSTITUTIONS) RESPONDED TO OUR CALL FOR ON SITE VISIT. MANUFACTURER (WAVERLY GLEN) DID NOT RESPOND TO US ON FIRST DAY OF INCIDENT BUT DID REPLY VIA EMAIL AND TELEPHONE ON THE FOLLOWING MORNING. A MANUFACTURER REPRESENTATIVE WAS ON SITE THE NEXT DAY. MEETINGS WITH THE MANUFACTURER RESULTED IN OFFER OF REPLACEMENT OF CARRIER BAR TO NEWER MODEL WHICH THEY NOTED HAD REPLACED THE PLASTIC PIECE WITH METAL. THE HOSPITAL REQUESTED DOCUMENTS AND VALIDATION OF TESTING OF THE NEW MODEL CARRIER BARS. AFTER SEVERAL CONVERSATIONS AND MEETINGS, THE HOSPITAL ACCEPTED THE NEWER VERSION CARRIER BARS AND IS IMPLEMENTING INTO SERVICE. THE HOSPITAL ALLOWED THE MANUFACTURER TO VISUALLY INSPECT THE BROKEN PIECES BUT DID NOT RELEASE TO THEM, NO PLAN TO DO SO. THE HOSPITAL ALSO ENCOURAGED MANUFACTURER TO REPORT TO FDA TO ALERT OTHER USERS OF FAILURE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?MOVING PATIENT USING THE CEILING LIFT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
36170 WAVERLY GLEN LIFT, PATIENT FSA PRISM MEDICAL * *

Patients

Seq Age Sex Outcome Treatment
1 *