FDA Adverse Event
Malfunction
Summary report: N
DRAEGER IACS C700
MDR report key: 5842820
·
Received July 29, 2016
Report
- Report Number
- MW5063782
- Event Type
- Malfunction
- Date Received
- July 29, 2016
- Date of Event
- July 6, 2016
- Report Date
- July 29, 2016
- Manufacturer
- DRAEGER
- Product Code
- MHX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE ECG DEFAULT SETTINGS ON THE DRAEGER IACS C700 SOFTWARE VG3 MONITOR WERE LEAD II FOR CHANNEL 1 AND LEAD V FOR CHANNEL 2. ECG MONITORING WAS DONE USING A 6 LEAD MONOLEAD ECG LEAD-WIRE SET. THE RA LEAD CAME OFF, ALARMED ECG LEADS OFF AND BOTH CHANNEL 1 - LEAD II AND CHANNEL 2 - V2 WERE LOST AT THE IACS C700 AND AT THE INFINITY CENTRAL STATION (ICS). THE IACS C700 DOES NOT HAVE ECG LEAD FALL BACK IN ORDER TO CONTINUE ARRHYTHMIA MONITORING EVEN THOUGH LEAD III COULD BE VIEWED VIA THE TAB "SHOW ALL" IN THE ECG SETUP. IN ADDITION, WHEN THE RA LEAD CAME OFF, THE REMAINING LEAD III DID NOT TRANSMIT TO THE ICS AND NO ECG WAVEFORMS WERE SAVED IN FULL DISCLOSURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 486921 | DRAEGER IACS C700 | DRAEGER IACS C700 | MHX | DRAEGER | |||
| 486922 | LEAD | LEAD | MHX | ||||
| 486923 | LEAD | LEAD | MHX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other |