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.
[125342840]
Upon receipt at our post market quality assurance laboratory the allegation against the communicator was confirmed. The electrical over stress (eos) caused the communicator issue. The returned power brick was melted at the prongs. The prongs of the power brick appeared to be shorted across while the power adapter was plugged in. There were signs of arcing and melting on the prongs.
Patient Sequence No: 1, Text Type: N, H10
[125342841]
Boston scientific received information that the communicator power cord caught fire. A melted power cord and surge protector was reported by the patient. The company representative verified that there were no injuries and property damage occurred. The patient stated that the circuit breaker was tripped and the electricity was lost. The communicator will be replaced and a return label will be sent to the patient. The communicator was deactivated. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2018-14831 |
| MDR Report Key | 8015531 |
| Report Source | CONSUMER |
| Date Received | 2018-10-29 |
| Date of Report | 2018-07-09 |
| Date of Event | 2018-07-09 |
| Date Mfgr Received | 2018-07-09 |
| 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 | 2018-07-27 |
| 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 | 293 | 2018-10-29 |