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

Model Number 3700

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Injury (2348)

Event Date 02/17/2014

Event Type  malfunction  

Event Description

The account reported the pt fell off of the bed due to the lift off foot section falling down.The account stated the left stirrup was off to the side and the pt put her knee on the bed to get onto the bed and the lift off section did not support her weight and gave out.The bed was located in birthing center (b)(4) at the facility.The pt was treated at the facility for a knee and elbow injury due to the fall.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The nurse reported to the hospital engineering dept that a pt was attempting to get back into bed and put her knee on the foot section mattress and the foot section did not support her weight and the foot section and pt fell.It was reported that the pt sustained an injury to her knee and elbow.The technician inspected the lift off foot section and advised it appears that the foot section weldment was too narrow for the yoke assembly.The technician advised that if he slid the foot section to one side the foot section would drop out of the yoke.A search of the hill-rom maintenance on this bed in 2013.It is unk if the facility performed any other preventative maintenance on this bed.The technician installed a new lift off foot section to resolve the issue.The foot section that fell has been returned to hill-rom for analysis and a capa has been opened for investigation.Based on this info, no further action is required.

• Brand Name: AFFINITY 4 BIRTHING BED
• Type of Device: BIRTHING BED
• Manufacturer (Section D): HILL-ROM INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state route 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3775867
• MDR Text Key: 4372769
• Report Number: 1824206-2014-01004
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• Is this an Adverse Event Report?: Yes
• 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: 02/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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
• Patient Outcome(s): Other