FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 3030841
·
Received March 28, 2013
Report
- Report Number
- 1828100-2013-00296
- Event Type
- Malfunction
- Date Received
- March 28, 2013
- Date of Event
- March 8, 2013
- Report Date
- March 8, 2013
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEM CORP
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) INSTALLED THE ORIGINAL O2 SENSOR AND IT CALIBRATED FINE. THEIR BIOMED WAS TRAINED BY THE MANUFACTURER ON THIS UNIT. EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE OXYGEN (O2) SENSOR PREVENTED THE ELECTRONIC PT GAS SYSTEM (EPGS) FROM CALIBRATING. ERROR CODE 23-4003, CAN NOT CALIBRATE OCCURRED. THE SENSOR SHELF LIFE WAS GOOD UNTIL (B)(6) 2013 AND WAS NOT WET OR DAMAGED. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 127777 | TERUMO ADVANCED PERFUSION SYSTEM 1 | DTQ | TERUMO CARDIOVASCULAR SYSTEM CORP | 801188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |