FDA Adverse Event
Malfunction
Summary report: N
BV25 + DIGITAL MEMORY
MDR report key: 2013563
·
Received February 2, 2011
Report
- Report Number
- 3003768277-2011-00065
- Event Type
- Malfunction
- Date Received
- February 2, 2011
- Report Date
- January 4, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- JAA
- PMA / PMN Number
- 8710539
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS EVENT IS STILL UNDER INVESTIGATION. THE F/U REPORT WILL BE SENT BY 4/2/2011.
Description of Event or Problem · 1
THE CUSTOMER SAID "X-RAY STOPS MIDWAY THROUGH".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BV25 + DIGITAL MEMORY | MOBILE X-RAY | JAA | PHILIPS HEALTHCARE | 71807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |