FDA Adverse Event Malfunction Summary report: N

TOTAL CARE BED

MDR report key: 3810381 · Received April 11, 2014

Report

Report Number
1824206-2014-01159
Event Type
Malfunction
Date Received
April 11, 2014
Date of Event
March 14, 2014
Report Date
March 14, 2014
Manufacturer
HILL-ROM INC.
Product Code
FNL
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
LA, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

THE TECHNICIAN WAS NOT SURE THE CAUSE OF THE SIDE COM BOARD FAILED BUT IT WAS MOST LIKELY DUE TO NORMAL WEAR AND TEAR. THE BED WAS DELIVERED TO THE ACCOUNT IN 1998 AND THE SIDE COM HAS NEVER BEEN RECORDED AS REPLACED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2012 THROUGH 2014. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE SIDE COM POWER CONTROL BOARD ASSEMBLY WAS REPLACED TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem · 1

THE TECHNICIAN REPORTED THAT THE NURSE CALL ALARM WOULD NOT TRANSIT TO THE NURSES' STATION DUE TO THE SIDE COM BOARD NOT FUNCTIONING. THE BED WAS LOCATED IN ROOM 3017 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
221683 TOTAL CARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 1900

Patients

Seq Age Sex Outcome Treatment
1