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

Model Number #C-8

Device Problems Inflation Problem (1310); Device Operates Differently Than Expected (2913)

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

Event Date 08/02/2016

Event Type  malfunction  

Event Description

Manifold malfunctioned.Heating unit not operating as expected.The bed was not inflating.

• Brand Name: CLINITRON RITE-HITE
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 5966292
• MDR Text Key: 55240331
• Report Number: 5966292
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2016,08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: #C-8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR