FDA Adverse Event
Malfunction
Summary report: N
ROTOPRONE
MDR report key: 3820624
·
Received April 11, 2014
Report
- Report Number
- 3010048749-2014-00049
- Event Type
- Malfunction
- Date Received
- April 11, 2014
- Date of Event
- March 27, 2014
- Report Date
- March 27, 2014
- Manufacturer
- ARJOHUNTLEIGH, INC
- Product Code
- IKZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED BY THE MANUFACTURER ARJHUNTLEIGH, INC. (REGISTRATION #(B)(4)). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FROM THE MANUFACTURING SITE KINETIC CONCEPTS, IN (UNDER REGISTRATION #(B)(4)). AS OF (B)(4)2012, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH, INC. AND REGISTRATION #(B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER INVESTIGATION.
Description of Event or Problem · 1
THE FOLLOWING WAS REPORTED TO ARJOHUNTLEIGH BY THE NURSE: ON (B)(6) 2014, THE TOUCH SCREEN ON THE ROTOPRONE FROZE AND WOULD NOT ACCEPT COMMANDS. THERE WAS NO PT INJURY. THE BED WAS ABLE TO BE MANUALLY ROTATED AS NEEDED UNTIL THE PT WAS TRANSFERRED TO A NEW BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221623 | ROTOPRONE | IKZ | ARJOHUNTLEIGH, INC | 209500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |