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

Model Number 3700

Device Problem Device Slipped (1584)

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

Event Date 04/22/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the brakes were not holding.The bed was located at the account.There was no patient/user injury reported.This report was file din our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The account found the brake detent was broken.Per the hill-rom service manual the affinity three birthing bed and affinity four birthing beds require and effective maintenance program.We recommend that you perform semiannual preventive maintenance.Check the tires for cuts, wear, tread life, etc.Apply the brake, and check to ensure that the bed will not move.If the bed moves, inspect it for wear, and adjust if required.Apply the steering pedal and check the steering to ensure proper locking action when activated.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2010-2012.It is unknown if the facility performed any other preventative maintenance on this bed.The account replaced the brake detent to resolve the issue.Based on this information, no further action is required.

• Brand Name: AFFINITY THREE 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: 3896295
• MDR Text Key: 4648118
• Report Number: 1824206-2014-01543
• 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: Other
• Type of Report: Initial
• Report Date: 04/22/2014

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/22/2014
• Initial Date FDA Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2004
• 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