FDA Adverse Event
Malfunction
Summary report: N
COMPACT MONITOR DISPLAY
MDR report key: 2123544
·
Received June 9, 2011
Report
- Report Number
- 9610816-2011-00308
- Event Type
- Malfunction
- Date Received
- June 9, 2011
- Report Date
- May 17, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K001664
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED A SPEAKER MALFUNCTION INOP MESSAGE ALONG WITH NO AUDIBLE SOUND. NO PATIENT HARM WAS REPORTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A SPEAKER MALFUNCTION INOP MESSAGE ALONG WITH NO AUDIBLE SOUND. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPACT MONITOR DISPLAY | MHX, DRT | MHX | PHILIPS MEDICAL SYSTEMS | M3046A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |