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

Device Problems Hole In Material (1293); Leak/Splash (1354); Material Rupture (1546)

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

Event Date 09/07/2015

Event Type  malfunction  

Event Description

Lining of clintron (rental) bed noted to have hole in it.Patient and patient's room became covered in fine sand material as it began to leak out of the mattress.Staff reported the sand was "shooting" out of the mattress.It is unknown at this time how the lining was punctured.Patient was removed from the room and the bed was taken out of service.There is no known patient injury at this time.This bed was a rental.

• Brand Name: CLINITRON RITE HITE
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; j34; batesville, IN 47006
• MDR Report Key: 5109764
• MDR Text Key: 27020023
• Report Number: 5109764
• 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: Patient
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 83 YR