MAUDE Adverse Event Report: HILL-ROM, INC. CLINITRON RITEHITE; BED, AIR FLUIDIZED

Model Number 0800

Device Problem Device Inoperable (1663)

Patient Problem Injury (2348)

Event Date 06/11/2015

Event Type  Injury  

Event Description

Hill-rom received a report from the account stating on (b)(6) 2015 the patient had flap surgery, on the event of (b)(6) 2015, the light flickered due to a storm and the nurse did not notice the bed had not come back on.The patient had laid on the bed for 5 hours before they realized it was not working.The plastic surgeon felt the flap surgery failed due to the bed not working properly and the patient had received a deep tissue injury that required another flap surgery on (b)(6) 2015.The bed was located at the account.This report was filed in our complaint handling system as complaint (b)(4).

Manufacturer Narrative

The hill-rom technician found the microspheres were wet and he swapped the bed out to resolve the issue.

• Brand Name: CLINITRON RITEHITE
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006
• MDR Report Key: 4909633
• MDR Text Key: 6032010
• Report Number: 1824206-2015-00715
• 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: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 0800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2015
• Initial Date FDA Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other