FDA Adverse Event
Malfunction
Summary report: N
MP70 INTELLIVUE PATIENT MONITOR
MDR report key: 2132422
·
Received June 14, 2011
Report
- Report Number
- 9610816-2011-00329
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Report Date
- May 29, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DSI
- PMA / PMN Number
- K021300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED THAT THEY DID NOT RECEIVE AN EXPECTED ALARM FROM A SPECIFIC MONITOR (BED 8). 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 THEY DID NOT RECEIVE AN EXPECTED ALARM FROM A SPECIFIC MONITOR (BED 8). NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MP70 INTELLIVUE PATIENT MONITOR | DSI | PHILIPS MEDICAL SYSTEMS | M8007A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |