FDA Adverse Event
Malfunction
Summary report: N
ACT III SENSOR
MDR report key: 2102880
·
Received May 4, 2011
Report
- Report Number
- 3027765-2011-00016
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Date of Event
- March 31, 2011
- Report Date
- April 4, 2011
- Manufacturer
- LIFEWATCH SERVICES, INC.
- Product Code
- DSI
- PMA / PMN Number
- K101703
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PRELIMINARY EVALUATION WAS PERFORMED BY LIFEWATCH, AND THE DEVICE PASSED ALL ASPECTS OF TESTING. THE DEVICE AND DATA FILES WERE SENT TO THE MANUFACTURER ON (B)(4) 2011 FOR ADDITIONAL ANALYSIS. ASSOCIATED ACCESSORY DEVICE: ACT MONITOR, MODEL # COM001, (B)(4).
Description of Event or Problem · 1
A 4.8 SECOND PAUSE WAS RECORDED BY THE DEVICE ON (B)(6) 2011 AT 4:10AM CST, BUT IT DID NOT TRIGGER AND SUBSEQUENTLY DID NOT TRANSMIT TO THE MONITORING CENTER. THE PATIENT CONTACTED HER PHYSICIAN AT APPROXIMATELY 11:00PM EST NIGHT AND WAS INSTRUCTED TO PRESENT AT THE EMERGENCY ROOM. THE MORNING OF (B)(6) 2011, THE PATIENT HAD A PACEMAKER IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACT III SENSOR | DETECTOR AND ALARM, ARRHYTHMIA | DSI | LIFEWATCH SERVICES, INC. | DEV060 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Other |