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

Model Number 3700

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Injury (2348)

Event Date 03/11/2014

Event Type  Other  

Event Description

The account reported that the pt was trying to get in the bed by the foot section and the foot section dropped and the pt fell to the floor.The bed was located in the labor and delivery at the facility.(b)(6) alleged that the pt was injured.This report was filed in our complaint handling system as complaint (b)(4).

Manufacturer Narrative

The tech investigated the alleged incident and found that when the foot section was installed and if the foot section was slid to one side if it was just tapped with a finger, the foot section fell to the ground.The suspect foot section measured 20 1/4 inches at the shoulder of the brackets and 20 1/8 at the tips.The right side bracket appeared to have a slight bend to it, it was unsure if this was a result of the pt falling on it.The hill-rom rep spoke with the tech to clarify the malfunction and the tech stated that even if the bracket was not bent, the foot section is narrower than the yoke and does not engage the receiving brackets.The foot section has been sent back to hill-rom for further investigation.The hill-rom rep spoke with the account's vp of quality and she advised the pt sustained minor scratches and bruises.Medical intervention was not required.The incident occurred post-delivery of the baby.Extended hospitalization was not required.The reported injury is non-serious in nature per fda definition.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.The foot section was replaced by the tech to resolve the issue.Based on this info, no further action is required.

• Brand Name: AFFUBUTT 4 BIRTHING BED
• Type of Device: BIRTHING BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state route 46 e; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3767703
• MDR Text Key: 4465687
• Report Number: 1824206-2014-01130
• 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: Other
• Type of Report: Initial
• Report Date: 03/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2014
• 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: 03/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2011
• 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