FDA Adverse Event
Summary report: N
MAC VU
MDR report key: 16564
·
Received June 15, 1994
Report
- Report Number
- MW4000490
- Date Received
- June 15, 1994
- Report Date
- June 15, 1994
- Manufacturer
- MARQUETTE ELECTRONICS, INC.
- Product Code
- DPS
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
EKG MACHINE WAS FOUND TO LOCK UP WHILE MONITORING A PT THAT HAD A DUAL CHAMBER PACING MODE. PACEMAKER IMPLANTED. THE PACEMAKER WAS OPERATED IN THE PT DEPENDENT MODE AT A RATE OF 100 BPM, PSA.6V, SA VENT .7MA, VENT 774 OHMS, VENT SLOW RATE 3.17V, VENT PEAK 22.2 MM V, FSA ATR .8 MA, ATR RES 866 OHMS, P-WAVE AMP 2.0 MV, F-WAVE AMP 1.8 MV. THE EKG MACHINE SEEMS TO HAVE SOME SORT OF SOFTWARE GLITCH WHICH CAUSES THE MACHINE TO LOCK UP UNDER THESE CONDITIONS. THE MFR WAS NOTIFIED OF THE PROBLEM. NO PT INCIDENT WAS REPORTED SINCE THIS DID NOT CAUSE ANY ADVERSE PT PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAC VU | EKG MACHINE | DPS | MARQUETTE ELECTRONICS, INC. | MAC VU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |