FDA Adverse Event
Malfunction
Summary report: N
SURESIGNS VS3
MDR report key: 2843852
·
Received October 24, 2012
Report
- Report Number
- 1218950-2012-03590
- Event Type
- Malfunction
- Date Received
- October 24, 2012
- Report Date
- September 24, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K082280
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DUE TO THE ALLEGATION OF "NO ALARM VOLUME" AND THE LACK OF RESPONSE FROM THE FIELD REGARDING THE MATTER, THE ORIGINAL ALLEGATION OF NO ALARM VOLUME IS ENOUGH TO ERR ON THE SIDE OF CAUTION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO 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 "NO ALARM VOLUME."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURESIGNS VS3 | MHX | PHILIPS MEDICAL SYSTEMS | 863069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |