FDA Adverse Event Malfunction Summary report: N

VERSACARE BED

MDR report key: 3820645 · Received May 6, 2014

Report

Report Number
1824206-2014-01391
Event Type
Malfunction
Date Received
May 6, 2014
Date of Event
April 8, 2014
Report Date
April 8, 2014
Manufacturer
HILL-ROM, INC.
Product Code
FNL
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
NE, US
Reporter Occupation
UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

THE ACCOUNT FOUND THE SIDE COM CABLE WAS DISCONNECTED. THE ACCOUNT WAS UNAWARE HOW THE CABLE HAD BECOME DISCONNECTED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE ACCOUNT RECONNECTED THE SIDE COM CABLE TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem · 1

THE ACCOUNT REPORTED THE BED WILL NOT SEND A NURSE CALL. THE BED WAS LOCATED IN GENERAL MED SURGE AT 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
271856 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

Patients

Seq Age Sex Outcome Treatment
1