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 01/06/2015

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found all four casters rubber wheels are worn out from wear and tear causing bed to slightly move.Per the hill-rom service manual, the affinity three birthing bed and affinity four birthing beds require an effective maintenance program.We recommend that you perform semiannual preventative 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 2012-2014.It is unk if the facility performed any other preventative maintenance on this bed.The technician replaced all four brake casters to resolve the issue.Based on this info, no further action is required.

Event Description

Hill-rom received a report from the account stating that the brakes were not holding.The bed was located at the account.There was no pt/user injury reported.(b)(4).

• Brand Name: AFFINITY 4 BED
• Type of Device: BIRTHING BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: john cummings ; 1069 state rte 46 e; batesville, IN 47006 ; 8129312869
• MDR Report Key: 4483463
• MDR Text Key: 21214876
• Report Number: 1824206-2015-00149
• 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: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• 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
• Date Manufacturer Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2008
• 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