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

Model Number 3700

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 08/13/2014

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician inspected the bed and found the brakes were not holding.He provided the account with an estimate for parts and labor.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 did not show hill-rom performed any preventative maintenance on this bed.It is unk if the facility performs preventative maintenance on their beds.No further info is available on the repair of the bed at this time.The investigation is ongoing, however, if any additional relevant info is identified following completion of the investigation, the additional relevant info will be submitted in a supplemental report.

Event Description

Hill-rom received a report from the account stating the bed has a brake problem.The bed was located at the account.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: AFFINITY 4 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: 4080665
• MDR Text Key: 19455455
• Report Number: 1824206-2014-02179
• Device Sequence Number: 1
• Product Code: KNC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K915779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• 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: 08/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2009
• 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