MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-10-29 for COMMUNICATOR 6290 manufactured by External Manufacturer.
[125441830]
Upon receipt at our post market quality assurance laboratory that the allegation against the power adapter was confirmed. The returned power brick measured zero volts and appears a liquid substance was spilled on the power brick causing corrosion on the blade adaptor? S prongs in which induce failure. The steady green button at the back of the communicator indicates normal operation of the communicator.
Patient Sequence No: 1, Text Type: N, H10
[125441831]
Boston scientific received information that the patient stated the power cord was burned at the electrical outlet. A boston scientific company representative verified that the patient was away and the communicator was plugged into an extension cord. The company representative then opted to replace the communicator and the power cord. The communicator was deactivated. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2018-19203 |
| MDR Report Key | 8015520 |
| Report Source | CONSUMER |
| Date Received | 2018-10-29 |
| Date of Report | 2018-07-18 |
| Date of Event | 2018-07-11 |
| Date Mfgr Received | 2018-07-18 |
| Date Added to Maude | 2018-10-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TIM DEGROOT |
| Manufacturer Street | 4100 HAMLINE AVE. N |
| Manufacturer City | ST. PAUL MN |
| Manufacturer Phone | 6515826168 |
| Manufacturer G1 | EXTERNAL MANUFACTURER |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMMUNICATOR |
| Generic Name | ACCESSORY |
| Product Code | OSR |
| Date Received | 2018-10-29 |
| Returned To Mfg | 2018-08-02 |
| Model Number | 6290 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXTERNAL MANUFACTURER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-29 |