MAUDE Adverse Event Report: HILL-ROM BATESVILLE AFFINITY FRAME; BIRTHING BED

Model Number P3605EA00

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/04/2017

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the brake/steer casters and detent mechanism needed to be replaced.Per the hill-rom service manual the affinity bed requires an effective maintenance program.We recommend that you perform semi-annual preventative maintenance.Check the tires for cuts, wear, tread life, etc.Apply the brake and check to ensure that the bed will not move (when the brake is activated).If the bed moves, inspect it for wear and adjust if required.See ¿caster assembly¿ on page 4-99.Apply the steering pedal and check the steering to ensure proper locking action when activated.See ¿caster assembly¿ on page 4-99.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the brake/steer casters and detent mechanism to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the brakes were not working properly.The bed was located at 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 FRAME
• Type of Device: BIRTHING BED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: erin padgett ; 1069 state route 46 east; batesville, IN 47006 ; 8129312791
• MDR Report Key: 6649528
• MDR Text Key: 78036420
• Report Number: 1824206-2017-00255
• Device Sequence Number: 1
• Product Code: FNL
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: P3605EA00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2001
• 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