MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-05-03 for COMMUNICATOR 6288 manufactured by External Manufacturer.
[107261946]
Upon receipt at our post market quality assurance laboratory signs of a pest infestation were noted within the communicator prohibiting analysis. As no further information concerning this report is expected, our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[107261947]
Boston scientific received information that a staff member of the patient's care facility was shocked while moving this communicator. It was noted that unknown to the staff member, the power supply sections became disconnected while moving furniture leaving the connector pins exposed on the portion of the cord still plugged into the outlet. Upon making contact with the pins, the staff member received a shock and minor burns. No additional adverse effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[107404272]
Patient Sequence No: 1, Text Type: N, H10
[107404273]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2018-07931 |
| MDR Report Key | 7484098 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-05-03 |
| Date of Report | 2018-03-28 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-03-28 |
| Device Manufacturer Date | 2015-07-28 |
| Date Added to Maude | 2018-05-03 |
| 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 | ILQ |
| Date Received | 2018-05-03 |
| Returned To Mfg | 2018-04-24 |
| Model Number | 6288 |
| ID Number | LATITUDE WAVE COMMUNICATOR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXTERNAL MANUFACTURER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2018-05-03 |