FDA Adverse Event Malfunction Summary report: N

AFFINITY BED

MDR report key: 2031576 · Received March 21, 2011

Report

Report Number
1824206-2011-01695
Event Type
Malfunction
Date Received
March 21, 2011
Date of Event
September 9, 2009
Report Date
September 9, 2009
Manufacturer
HILL-ROM, INC.
Product Code
HDD
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
UK
Reporter Occupation
UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

ACCOUNT ADJUSTED THE BRAKE AND STEER CASTERS TO RESOLVE THE ISSUE. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.

Description of Event or Problem · 1

ACCOUNT ALLEGED THAT THE BRAKES WERE NOT LATCHING. NO PT IMPACT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 AFFINITY BED BIRTHING BED HDD HILL-ROM, INC. 3700

Patients

Seq Age Sex Outcome Treatment
1