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 06/04/2015

Event Type  malfunction  

Event Description

Hill-rom received a report form the account stating the brakes were not holding.The bed was located in labor and delivery at the account.There was no patient/user injury reported.This report was filed in our complain handling system as complaint #(b)(4).

Manufacturer Narrative

The technician found the detent assembly was missing some pieces.A search of the hill-rom maintenance showed hill-rom performed preventative maintenance on this bed in 2009-2015.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the detent assembly to resolve the issue.Based on this information, no further action is required.

• 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: 4890621
• MDR Text Key: 21065653
• Report Number: 1824206-2015-00691
• Device Sequence Number: 1
• Product Code: HDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K91579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• 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: 06/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1