MAUDE Adverse Event Report: HILL-ROM BATESVILLE CLINITRON AT*HOME; BED FLOTATION THERAPY POWERED

Model Number P0800010016

Device Problem Unintended Head Motion (1284)

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

Event Date 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

Hill-rom technical support suggested removing the hand pendant to see if this stops the issue.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.No further information is available on the repair of the bed at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

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 the patients home.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Type of Device: BED FLOTATION THERAPY POWERED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 5035519
• MDR Text Key: 24297508
• Report Number: 1824206-2015-00849
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK942184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Report Date: 08/04/2015

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: Lay User/Patient
• Device Model Number: P0800010016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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