FDA Adverse Event
Malfunction
Summary report: N
O-ARM 1000 IMAGING SYSTEM
MDR report key: 2081181
·
Received April 21, 2011
Report
- Report Number
- 1723170-2011-00865
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- August 10, 2010
- Report Date
- August 10, 2010
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- IZL
- PMA / PMN Number
- K050996
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PER MEDTRONIC REP ADJUSTED THE DOOR SIDE SWITCH AND REPLACED SYSTEM CONTROL AND MOTION CONTROL BOARD. THIS RESOLVED THE ISSUE. PARTS HAVE NOT BEEN RETURNED FOR EVALUATION.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED, THE DOOR WOULDN'T OPEN ON THE O-ARM. DOOR OVERRIDE BUTTON DID NOT WORK EITHER. REPEATED LOSS OF HOME, RESULTS IN ERROR MESSAGE INDICATING THE USER SHOULD HOLD DOWN M; WHEN RADIOGRAPHER DOES THIS, O-ARM MOVEMENT KNOCKED INTO PATIENT TABLE. THE SURGEON DECIDED TO DISCONTINUE THE USE OF THE SYSTEM WITH NO IMPACT ON PATIENT OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | O-ARM 1000 IMAGING SYSTEM | SYSTEM, XRAY, MOBILE (IZL) | IZL | MEDTRONIC NAVIGATION, INC. | BI-700-00027-120 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |