FDA Adverse Event
Malfunction
Summary report: N
ACT 3 SENSOR
MDR report key: 1931717
·
Received November 22, 2010
Report
- Report Number
- 3027765-2010-00089
- Event Type
- Malfunction
- Date Received
- November 22, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 24, 2010
- Manufacturer
- LIFEWATCH SERVICES, INC.
- Product Code
- DSI
- PMA / PMN Number
- K081257
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS BEING SENT TO THE MFR, CARDGUARD, FOR FINAL ANALYSIS. FINAL ANALYSIS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON RECEIPT OF THE TEST RESULTS. ASSOCIATED ACCESSORY DEVICE: ACT MONITOR, MODEL# COM001, (B)(6).
Description of Event or Problem · 1
ON (B)(6) 2010, THE PT REPORTED THE RED ELECTRODE IS BURNING HIM. A REPLACEMENT DEVICE WAS ISSUED TO THE PT. ATTEMPTS AT TELEPHONE COMMUNICATION ON (B)(6) 2010, AND (B)(6) 2010 WERE UNSUCCESSFUL. A LETTER WAS MAILED TO THE PT REQUESTING HE CONTACT US TO OBTAIN FURTHER DETAILS ON THE REPORTED EVENT. AS OF (B)(6) 2010, THE PT HAS NOT RETURNED OUR CALLS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACT 3 SENSOR | DETECTOR AND ALARM, ARRHYTHMIA | DSI | LIFEWATCH SERVICES, INC. | DEV060 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other |