FDA Adverse Event
Malfunction
Summary report: N
EXCITEOSA
MDR report key: 12075118
·
Received June 28, 2021
Report
- Report Number
- 3017737771-2021-00001
- Event Type
- Malfunction
- Date Received
- June 28, 2021
- Date of Event
- April 13, 2021
- Report Date
- April 19, 2021
- Manufacturer
- SIGNIFIER MEDICAL TECHNOLOGIES LTD
- Product Code
- QNO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
REPORTED ON (B)(6) 2021 BY MANUFACTURER VIA FORM 3500A MEDWATCH DUE TO WEBTRADER ACCOUNT NOT BEING APPROVED YET, REFERENCE MW5101367. THIS REPORT IS BEING RESUBMITTED WITH A NEW MFR REPORT NUMBER AS IT WAS SUBMITTED WITH INCORRECT REPORT SEQUENCE NUMBER 3017737771-2021-00000 ON (B)(6) 2021.
Description of Event or Problem · 0
USER LEFT THEIR CONTROL UNIT TO CHARGE OVERNIGHT WITH THE SUPPLIED USB CABLE. WHEN THEY ATTENDED TO THE CONTROL UNIT AFTER HOURS OF CHARGING (ON (B)(6) 2021), THEY FOUND THAT THE CONTROL UNIT AND CABLE WAS HOT AND HAD MELTED SLIGHTLY AT THE CONNECTION POINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 978082 | EXCITEOSA | EXCITEOSA | QNO | SIGNIFIER MEDICAL TECHNOLOGIES LTD | 3000 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |