FDA Adverse Event
Malfunction
Summary report: N
BSZ
MDR report key: 3814910
·
Received April 21, 2014
Report
- Report Number
- 3010587095-2014-00009
- Event Type
- Malfunction
- Date Received
- April 21, 2014
- Report Date
- March 21, 2014
- Manufacturer
- PHILIPS ANESTHESIA CARE
- Product Code
- BSZ
- PMA / PMN Number
- K122063
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE USERS REPORTED THAT THE KNOB FOR THE FLOWMETER FELL OFF. THE LOCAL FIELD SERVICE ENGINEER DETERMINED THAT THE KNOB THAT FELL OFF WAS FOR THE AUXILIARY O2 ROTAMETER. THIS AUXILIARY O2 ROTAMETER IS NOT PART OF EITHER AUTOMATED OR MANUAL VENTILATION DELIVERY. IF THE KNOB FELL OFF, THE DEVICE USER MAY NOT BE ABLE TO CHANGE THE SETTING ON THIS AUXILIARY O2 ROTAMETER. PHILIPS HAS NOT BEEN ABLE TO RULE OUT THAT THIS COULD BE A HEALTH RISK IF IT RECURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241342 | BSZ | DAMECA, GAS-MACHINE, ANESTHESIA | BSZ | PHILIPS ANESTHESIA CARE | 866205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |