FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 1890788
·
Received November 1, 2010
Report
- Report Number
- 1828100-2010-02115
- Event Type
- Malfunction
- Date Received
- November 1, 2010
- Date of Event
- October 6, 2010
- Report Date
- November 1, 2010
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CTR, THE USER REPORTED THE CENTRAL CONTROL MONITOR DID NOT FUNCTION AS EXPECTED. THE CURSOR ON THE MONITOR SCREEN WAS ABOUT 3/4 OF AN INCH OFF FROM WHERE THE MONITOR WAS ACTUALLY TOUCHED. THE CURSOR ALIGNMENT ISSUE WAS LOCALIZED TO THE BOTTOM CENTER OF THE SCREEN. THE MONITOR WAS ORIGINALLY RETURNED FOR REPAIR OF A DISTORTED DISPLAY WHEN THE TOUCHSCREEN ISSUE WAS FOUND. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING OF THE DEVICE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO ADVANCED PERFUSION SYSTEM 1 | CENTRAL CONTROL MONITOR | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 816300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |