FDA Adverse Event Malfunction Summary report: N

ADVANTA BED

MDR report key: 3881783 · Received May 27, 2014

Report

Report Number
1824206-2014-01641
Event Type
Malfunction
Date Received
May 27, 2014
Date of Event
April 30, 2014
Report Date
April 30, 2014
Manufacturer
HILL-ROM, INC.
Product Code
FNL
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

THE TECHNICIAN FOUND THAT THE SIDE RAIL POWER CONTROL BOARD WAS INOPERABLE DUE TO A BENT PIN WHERE THE COMMUNICATION CABLE PLUGS INTO THE BED. MOST LIKELY CAUSE IS THE COMMUNICATION CABLE NOT BEING DISCONNECTED PROPERLY BEFORE THE BED IS TRANSPORTED. PER THE HILL-ROM MANUAL THE ADVANTA BED REQUIRES AN EFFECTIVE MAINTENANCE PROGRAM. PREVENTATIVE MAINTENANCE WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. COMMUNICATIONS: INSPECT AND TEST THE COMMUNICATION JUNCTION BOX. TEST THE SIDECOM COMMUNICATION SYSTEM FEATURES FOR PROPER OPERATION. INSPECT THE COMMUNICATION CABLE INCLUDING THE MALE AND FEMALE PINS IN THE PLUG. TEST THE NURSE CALL SUPER CAPACITOR FOR PROPER OPERATION. 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 REPLACED THE UNIVERSAL TELEVISION JUNCTION BOX POWER CONTROL BOARD ASSEMBLY TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem · 1

THE ACCOUNT REPORTED THE BED EXIT WOULD ONLY ALARM INTERMITTENTLY. THE BED WAS LOCATED IN (B)(6) 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
310708 ADVANTA BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1600

Patients

Seq Age Sex Outcome Treatment
1