FDA Adverse Event
Malfunction
Summary report: N
OMNIDIAGNOST ELEVA
MDR report key: 2080136
·
Received April 7, 2011
Report
- Report Number
- 3003768277-2011-00298
- Event Type
- Malfunction
- Date Received
- April 7, 2011
- Report Date
- March 10, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IZI
- PMA / PMN Number
- K032046
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE FOOTBOARD FELL OFF THE TABLE, WHILE PT WAS ON IT AND THE PT WAS (B)(6). THE PT SUSTAINED MINOR BRUISES WHEN SHE FELL OFF. FURTHER INFO RECEIVED INDICATES THAT THE PT WAS CHECKED BY THE HOSPITAL AND GIVEN A CLEAN BILL OF HEALTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNIDIAGNOST ELEVA | IZI, JAA, KPR | IZI | PHILIPS HEALTHCARE | 708027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |