FDA Adverse Event
Malfunction
Summary report: N
ANESTAR
MDR report key: 1424383
·
Received March 30, 2009
Report
- Report Number
- 2221819-2009-00003
- Event Type
- Malfunction
- Date Received
- March 30, 2009
- Date of Event
- January 8, 2009
- Report Date
- January 15, 2009
- Manufacturer
- MINDRAY DS USA, INC.
- Product Code
- BSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A COMPANY TECHNICAL SUPPORT REP CONFIRMED THAT WHILE THE TIDAL VOLUME DELIVERED WAS ACCURATE, THE TIDAL VOLUME DISPLAYED DID INCREASE, AND WAS INACCURATE INTERMITTENTLY. HE REPLACED THE MOD 2 BOARD, PART NUMBER 0997-00-0967. THE UNIT PERFORMED ACCORDING TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE THE ANESTHESIA MACHINE WAS IN USE ON A PT DURING A PROCEDURE, THE TIDAL VOLUME INCREASED ON ITS OWN. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANESTAR | ANESTHESIA MACHINE | BSZ | MINDRAY DS USA, INC. | ANESTAR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |