MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-15 for LATITUDE COMMUNICATOR 6290 manufactured by Jabil Circuit (shanghai) Ltd.
[175093875]
It was reported that the communicator blew up and damaged the power outlet. The patient stated that he had nothing laying over the communicator. The communicator just blew up on its own. The communicator is not functioning. A boston scientific company representative discussed with the patient and opted to replace the entire system. The communicator was deactivated. A return label was sent. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2019-27093 |
| MDR Report Key | 9592543 |
| Report Source | CONSUMER |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2019-12-18 |
| Date Added to Maude | 2020-01-15 |
| 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 | TIMOTHY DEGROOT |
| Manufacturer Street | 4100 HAMLINE AVENUE NORTH |
| Manufacturer City | SAINT PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6515826168 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATITUDE COMMUNICATOR |
| Generic Name | COMMUNICATOR |
| Product Code | OSR |
| Date Received | 2020-01-15 |
| Model Number | 6290 |
| Catalog Number | 6290 |
| Lot Number | 5297607 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JABIL CIRCUIT (SHANGHAI) LTD |
| Manufacturer Address | 600 TIAN LIN RD SHANGHAI CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-15 |