FDA Adverse Event
Malfunction
Summary report: N
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
MDR report key: 2000436
·
Received February 24, 2011
Report
- Report Number
- 2015691-2011-14870
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- January 7, 2011
- Report Date
- January 26, 2011
- Manufacturer
- EDWARDS LIFESCIENCES DR
- Product Code
- DXO
- PMA / PMN Number
- K925638
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE WAS RETURNED BECAUSE THE DEVICE WAS DISCARDED; THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED BY EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE DONE WITHOUT A LOT NUMBER. AFTER REVIEW OF THE AVAILABLE INFORMATION, A ROOT CAUSE COULD NOT BE DETERMINED. IT IS NOT KNOWN IF PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VAMP FLEX (B)(4) IS IN A NUMBER OF CASES GIVING AN OVERSHOOT OF THE ARTERIAL BLOOD PRESSURE WHILE CONNECTED TO THE PATIENT MONITOR. THIS HAPPENS AFTER THE DPT HAS BEEN ZEROED. THE OVERSHOOT APPEARS AS A LARGE SPIKE ON THE PATIENT MONITOR WHICH RUNS OUT OF THE LIMITS. ADDITIONAL INFORMATION AND CLARIFICATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER | DISPOSABLE PRESSURE TRANSDUCER | DXO | EDWARDS LIFESCIENCES DR | T005021G | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |