FDA Adverse Event Malfunction Summary report: N

TOTALCARE BED

MDR report key: 4213230 · Received October 3, 2014

Report

Report Number
1824206-2014-02387
Event Type
Malfunction
Date Received
October 3, 2014
Date of Event
September 6, 2014
Report Date
September 6, 2014
Manufacturer
HILL-ROM TECHNICIAN
Product Code
FNL
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

THE HILL-ROM TECHNICIAN FOUND THE LEFT SIDERAIL WOULD NOT LATCH. 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 TECHNICIAN ADJUSTED THE SIDERAIL TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem · 1

HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE LEFT SIDERAIL WAS BROKEN (SIDERAIL NOT LATCHING). THE BED WAS LOCATED AT THE ACCOUNT. 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
619402 TOTALCARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM TECHNICIAN 1840

Patients

Seq Age Sex Outcome Treatment
1