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 08/08/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the right hand pendant port was not functioning as intended.The technician moved the hand pendant to the left hand pendant port to resolve the issue.The right hand pendant port will be repaired at the conclusion of this rental period when the bed is not in use.Based on this information, no further action is required at this time.

Event Description

Hill-rom received a report from the account stating the head of the bed was going up and down on its own (self run).The bed was located at the account.There was no patient/user injury reported.(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: 7837385
• MDR Text Key: 119042258
• Report Number: 1824206-2018-00334
• 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: Other
• Type of Report: Initial
• Report Date: 08/08/2018

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: 08/08/2018
• Initial Date FDA Received: 08/31/2018
• 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: Reuse
• Patient Sequence Number: 1