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

Model Number P0800010019

Device Problem Unintended Movement (3026)

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

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the hand pendant was missing pins when connected to the bed.Per the hill-rom service manual, hand pendant malfunction: replace the hand pendant with a known good one, and test each of its functions.(rga the pendant removed from the unit.) all functions operate normally with the new pendant.Yes, no.Go to step 3.Go to ¿final actions." the head goes up and down when the appropriate hand pendant button is pushed.Yes, no.Go to rap 2.9.Disconnect the hand pendant in-line connector at the junction plate, and check the following voltages.Pin 1 (a) to pin 3 (b) (head up) = 5v dc.Pin 2 (c) to pin 3 (b) (head down) = 5v dc.Pin 4 (d) to pin 3 (b) (fluidization) = 5v dc.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in september 2016.It is unknown if the facility performed any other preventative maintenance on this bed.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 of the bed was moving on its own.The bed was located in room 414 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: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 6061580
• MDR Text Key: 58601425
• Report Number: 1824206-2016-00465
• 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: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/10/2016

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: Other Caregivers
• Device Model Number: P0800010019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 10/27/2016
• 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: Reuse
• Patient Sequence Number: 1