FDA Adverse Event
Malfunction
Summary report: N
COMPACT MONITOR DISPLAY
MDR report key: 1811173
·
Received August 13, 2010
Report
- Report Number
- 9610816-2010-00306
- Event Type
- Malfunction
- Date Received
- August 13, 2010
- Report Date
- July 5, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K001664
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT AN M3046A MONITOR FELL AND WAS DAMAGED. NO PATIENT HARM WAS REPORTED AS A RESULT OF THIS INCIDENT. 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 THAT AN (B)(4) MONITOR FELL AND WAS DAMAGED. NO PATIENT HARM WAS REPORTED AS A RESULT OF THIS INCIDENT.
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 |