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

Model Number P0800010019

Device Problem Unintended System Motion (1430)

Patient Problem No Patient Involvement (2645)

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the electrical box needed to be replaced.Press the head up button on the control panel.The head raises when button is pressed.Yes no go to rap 2.9.At the electrical box, connect the (+) meter lead to jp3-2 and the (-) meter lead to jp3-5 to test the head solenoid voltage.Observe the meter reading while pressing the head up button on the pendant control.When the button is pressed, the voltage measures approximately 33v dc.The head goes up and down when the appropriate hand pendant button is pushed.Yes no.Replace the ac board in the electrical box (refer to procedure 4.17).A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in july 2019.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the electrical box to resolve the issue.Based on this information, no further action is required.

Event Description

Hillrom received a report from the account stating the head of the bed was going up and down on its own.The bed was located in room 112 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: emily mitchell ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 8864604
• MDR Text Key: 153515605
• Report Number: 1824206-2019-00301
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2019

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: No Information
• Device Model Number: P0800010019
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/06/2019
• 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