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 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the hand pendant needed to be repaired.Per the hillrom 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 on page 2-6.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 (see figure 2-33 on page 2-78): 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 hillrom maintenance records showed hillrom performed preventative maintenance on this bed in (b)(6) 2019.It is unknown if the facility performed any other preventative maintenance on this bed.The technician repaired the hand pendant 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 moves up and down without pressing any buttons.The bed was located in room 5601 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: 9140468
• MDR Text Key: 219786152
• Report Number: 1824206-2019-00387
• 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
• Type of Report: Initial
• Report Date: 09/19/2019

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: 09/19/2019
• Initial Date FDA Received: 10/01/2019
• 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