FDA Adverse Event Malfunction Summary report: N

PROCEDURAL STRETCHER

MDR report key: 3940750 · Received April 22, 2014

Report

Report Number
3006697241-2014-00384
Event Type
Malfunction
Date Received
April 22, 2014
Date of Event
March 25, 2014
Report Date
March 25, 2014
Manufacturer
HILLROM DE MEXICO S DE RL DE CV
Product Code
FPO
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
MO, US
Reporter Occupation
UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

THE TECHNICIAN FOUND THE BRAKE MECHANISM WHERE THE HEX ROD ATTACHES IS NOT HOLDING THE HEX ROD SECURELY WHEN THE BRAKE PEDAL IS ENGAGED. THE MOST LIKELY CAUSE IS NORMAL WEAR AND TEAR. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2014. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE LEFT FOOT BRAKE CASTER WAS REPLACED BY THE TECHNICIAN TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem · 1

THE TECHNICIAN REPORTED THE LEFT FOOT BRAKE CASTER IS NOT HOLDING WHEN THE BRAKE PEDAL IS ENGAGED. THE STRETCHER WAS LOCATED IN THE BED SHOP ON THE 3RD FLOOR OF THE FACILITY. THERE WAS NO PATIENT/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
242617 PROCEDURAL STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8000

Patients

Seq Age Sex Outcome Treatment
1