MAUDE Adverse Event Report: HILL-ROM INC. AFFINITY THREE BIRTHING BED

Model Number 3700

Device Problem Device Slipped (1584)

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

Event Date 03/03/2014

Event Type  malfunction  

Event Description

The account reported the left side rail will not latch.The bed was located in labor and delivery at the facility.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The technician found the left side rail mounting bracket is bent.The most likely cause would be force such as the side rail was into a doorway during transport.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance records showed hill-rom performed preventative maintenance on this bed in 2006 through 2014.It is unk if the facility performed any other preventative maintenance on this bed.The technician straightened the left side rail mounting bracket to resolve the issue.Based on this information, no further action is required.

• Brand Name: AFFINITY THREE BIRTHING BED
• Type of Device: BIRTHING BED
• Manufacturer (Section D): HILL-ROM INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state rt 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3786926
• MDR Text Key: 4430878
• Report Number: 1824206-2014-01039
• Device Sequence Number: 1
• Product Code: HDD
• 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,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/03/2014

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
• Device Model Number: 3700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2014
• Initial Date FDA Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2001
• 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