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

Model Number 3700

Device Problem Self-Activation or Keying (1557)

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

Event Date 03/30/2015

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the head section would self-run when the bed is plugged in.The bed was located in rm 4513 at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The hill-rom tech found the right patient controls were the issue.A search of the hill-rom maintenance records did not show hill-rom performed preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The tech replaced the right side patient controls and the issue was resolved.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 rte 46 e; batesville, IN 47006 ; 8129312359
• MDR Report Key: 4737422
• MDR Text Key: 5768739
• Report Number: 1824206-2015-00537
• Device Sequence Number: 1
• Product Code: KNC
• 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: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• 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: 03/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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