FDA Adverse Event Malfunction Summary report: N

TRANSTAR SURGICAL STRETCHER

MDR report key: 3896780 · Received May 20, 2014

Report

Report Number
3006697241-2014-00463
Event Type
Malfunction
Date Received
May 20, 2014
Date of Event
April 22, 2014
Report Date
April 22, 2014
Manufacturer
HILLROM DE MEXICO S DE RL DE CV
Product Code
FPO
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
AK, US
Reporter Occupation
UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

THE TECHNICIAN FOUND THE BRAKE ROCKER ARM IS BROKEN. THE MOST LIKELY CAUSE IS NORMAL WEAR AND TEAR. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNK IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN ORDERED THE NECESSARY PARTS FOR REPAIR. NO FURTHER INFO IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. IF ANY ADDITIONAL RELEVANT INFO IS IDENTIFIED FOLLOWING COMPLETION OF THE REPAIR, THE ADDITIONAL RELEVANT INFO WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem · 1

THE TECHNICIAN FOUND THE BRAKES ARE NOT HOLDING. THE STRETCHER WAS LOCATED AT THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
299203 TRANSTAR SURGICAL STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8010

Patients

Seq Age Sex Outcome Treatment
1