MAUDE Adverse Event Report: HILL-ROM, INC. AFFINITY BED; BIRTHING BED

Model Number 3600

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2014

Event Type  malfunction  

Manufacturer Narrative

The technician found the brake caster were out of adjustment.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2007, 2008, 2010, 2011, 2013, and 2014.It is unknown if the facility performed any other preventative maintenance on this bed.The technician adjusted the brake caster to resolve the issue.Based on this info, no further action is required.

Event Description

Hill- rom rec'd a report from a hill-rom technician stating the brakes were not holding.The bed was located on the 1st floor of the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: AFFINITY BED
• Type of Device: BIRTHING BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 3958663
• MDR Text Key: 21156062
• Report Number: 1824206-2014-01508
• Device Sequence Number: 1
• Product Code: HDD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2014
• Initial Date FDA Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1995
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1