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

Model Number 3700

Device Problems Collapse (1099); Component Falling (1105)

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

Event Date 07/25/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating one of the casters fell off the bed resulting in the bed collapsing.The vest was located at the account in the deliver suite.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The hill-rom tech found when he arrived at the account the bed had been repaired by the hospital's service provider.A search for 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 tech performed a functional and visual check to verify the bed was functioning as designed.Based on this info, 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: john cummings ; 1069 state route 46 e; batesville, IN 47006 ; 8129312869
• MDR Report Key: 4077216
• MDR Text Key: 18539484
• Report Number: 1824206-2014-02146
• Device Sequence Number: 1
• Product Code: KNC
• Combination Product (y/n): N
• PMA/PMN Number: K915779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2014
• 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: 07/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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