MAUDE Adverse Event Report: HILL-ROM BATESVILLE AFFINITY 4 BED FRAME; BIRTHING BED

Model Number P3700D000008

Device Problem Positioning Problem (3009)

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

Event Date 02/06/2017

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technical support representative suggested that the brake casters needed to be replaced.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 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 2016.It is unknown if the facility performed any other preventative maintenance on this bed.Three attempts have been made regarding a resolution to this contact line, with no response.Based on this information, no further action is required.

Event Description

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

• Brand Name: AFFINITY 4 BED 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: 6356024
• MDR Text Key: 68511057
• Report Number: 1824206-2017-00082
• Device Sequence Number: 1
• Product Code: FNL
• 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: Hospital Service Technician
• Type of Report: Initial
• Report Date: 02/06/2017

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 Caregivers
• Device Model Number: P3700D000008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2013
• 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