FDA Adverse Event
Malfunction
Summary report: N
VS3: NBP, SP02, TEMP
MDR report key: 2259194
·
Received September 16, 2011
Report
- Report Number
- 1218950-2011-02628
- Event Type
- Malfunction
- Date Received
- September 16, 2011
- Report Date
- August 24, 2011
- Manufacturer
- PHILIPS HEALTHCARE - ANDOVER
- Product Code
- MHX
- PMA / PMN Number
- K082280
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THERE WAS A SPEAKER MALFUNCTION. 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 THAT THERE WAS A SPEAKER MALFUNCTION. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VS3: NBP, SP02, TEMP | MHX | PHILIPS HEALTHCARE - ANDOVER | 863073 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |