FDA Adverse Event
Malfunction
Summary report: N
COMMUNICATOR
MDR report key: 3212413
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-08571
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- May 24, 2013
- Report Date
- September 27, 2013
- Manufacturer
- EXTERNAL MANUFACTURER
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
- -
Additional Manufacturer Narrative · 1
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED. AFTER THE POWER SUPPLY WAS REPLACED, SUCCESSFUL DATA TRANSMISSION WAS VERIFIED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AFTER A RECENT POWER OUTAGE, WHEN THIS DEVICE WAS PLUGGED IN, A BURNING SMELL WAS NOTED. IN ADDITION, A "SISSING" NOISE WAS HEARD. THE GREEN LIGHT IS OFF ON THE POWER CABLE. A NEW POWER AND PHONE CORD WERE SENT TO THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313410 | COMMUNICATOR | ACCESSORY | LWS | EXTERNAL MANUFACTURER | 6468 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |