FDA Adverse Event
Injury
Summary report: N
ACT 3 SENSOR
MDR report key: 1822758
·
Received August 25, 2010
Report
- Report Number
- 3027765-2010-00078
- Event Type
- Injury
- Date Received
- August 25, 2010
- Date of Event
- July 21, 2010
- Report Date
- August 2, 2010
- Manufacturer
- LIFEWATCH SERVICES INC
- Product Code
- DSI
- PMA / PMN Number
- K081257
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IN HOUSE PRELIMINARY TESTING HAS NOT BEEN PERFORMED. ASSOCIATED ACCESSORY DEVICE: ACT MONITOR. MODEL# COM001. (B)(4).
Description of Event or Problem · 1
THE PT'S SECRETARY CALLED LIFEWATCH TO REPORT THAT THE PT PLACED NEW ELECTRODES ON HIS BODY ON (B)(6)2010 AND HIS SKIN WAS ALREADY PRETTY RAW. THE NEW ELECTRODES CREATED AN IMMEDIATE REACTION SO SEVERE THAT THE PT WAS RUSHED TO THE EMERGENCY ROOM. IN ORDER TO GATHER ADDITIONAL INFORMATION ON THE EVENT, ON (B)(6)2010 THE PT WAS CALLED AND THE ELECTRODE QUESTIONNAIRE WAS COMPLETED. THE PT STATED THAT WITHIN 15 MINUTES OF CHANGING THE ELECTRODES, HIS HANDS, FEET, AND EARS SWELLED. THE PT FELT WELTS ALL OVER HIS BODY, HIS BLOOD PRESSURE DROPPED AND HE PASSED OUT. THE PT WAS PRESCRIBED MEDICATION BUT DID NOT REMEMBER THE NAMES.
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 | 61 YR | Hospitalization |