MAUDE Adverse Event Report: HILL-ROM INC. AFFINITY 4 BED; BIRTHING BED

Model Number 3700

Device Problem Device Slipped (1584)

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

Event Date 06/23/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the brake was not holding.The bed was located at the account in (b)(6).There was no pt user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The hill-rom technician found the head right brake caster not holding.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 head right brake caster to resolve the issue.Based on this information, no further action is required.

• Brand Name: AFFINITY 4 BED
• Type of Device: BIRTHING BED
• Manufacturer (Section D): HILL-ROM INC.; batesville IN
• Manufacturer Contact: john cummings ; 1069 state rt 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 4009708
• MDR Text Key: 4689946
• Report Number: 1824206-2014-01994
• Device Sequence Number: 1
• Product Code: HDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/23/2014

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: 3700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2014
• Initial Date FDA Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2008
• 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