FDA Adverse Event
Malfunction
Summary report: N
INTELLIVUE MP2
MDR report key: 2240848
·
Received August 18, 2011
Report
- Report Number
- 9610816-2011-00493
- Event Type
- Malfunction
- Date Received
- August 18, 2011
- Report Date
- July 27, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K040357
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT A NURSE DISCOVERED BUBBLES UNDER A TRANSDUCER ON A PATIENT WHO COMPLAINED OF PAIN, HOWEVER NO PATIENT HARM WAS REPORTED. THE CUSTOMER HAS SENT IN THE SENSOR TO PHILIPS FOR REVIEW. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT 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 A NURSE DISCOVERED BUBBLES UNDER A TRANSDUCER ON A PATIENT WHO COMPLAINED OF PAIN, HOWEVER, NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELLIVUE MP2 | MHX | PHILIPS MEDICAL SYSTEMS | M8102A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |