FDA Adverse Event
Malfunction
Summary report: N
DIAGNOST 96
MDR report key: 2033660
·
Received February 11, 2011
Report
- Report Number
- 3003768277-2011-00148
- Event Type
- Malfunction
- Date Received
- February 11, 2011
- Report Date
- January 14, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- JAA
- PMA / PMN Number
- K912470
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 BY (B)(6) 2011.
Description of Event or Problem · 1
THE CUSTOMER REPORTED, "THE DEVICE TAKES ON IMAGE AND THEN NO LONGER TRIGGERS. IT HAS TO BE SHUT DOWN COMPLETELY TO TAKE AN IMAGE AGAIN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIAGNOST 96 | JAA | PHILIPS HEALTHCARE | 70827 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |