MAUDE Adverse Event Report: HILL-ROM BATESVILLE CLINITRON RITEHITE C-8 ASSY; BED, AIR FLUIDIZED

Model Number P0800010019

Device Problem Unintended Head Motion (1284)

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

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the hand pendant needed to be replaced.Per the hill-rom user manual: powered bed mechanisms can cause serious injury.Operate the bed only with persons clear of moving bed surfaces.If you are trying to access a hydraulic function from the control panel or pendant and the unit is not operating properly, the following message may appear: head position sensors not calibrated.Notify hill-rom a search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2017.The technician replaced the hand pendant to resolve the issue.Based on this information, no further action is required.

Event Description

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

• Brand Name: CLINITRON RITEHITE C-8 ASSY
• Type of Device: BED, AIR FLUIDIZED
• 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: 7243495
• MDR Text Key: 99332393
• Report Number: 1824206-2018-00065
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: P0800010019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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