MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-02-03 for NEUROMONICS OASIS TINNITUS TREATMENT DEVICE 110 NA manufactured by Neuromonics Inc..
[1053866]
Pt plugged in the device to charge it and placed it on a granite benchtop. The device was contained in its carrying pouch. The unit overheated rapidly and began to emit flames. Pt threw the device in a nearby sink to extinguish the flames and reported that his thumb was blistered in the process. Pt did not elect to seek medical treatment for the blistering. The device was significantly damaged and there was some smoke produced.
Patient Sequence No: 1, Text Type: D, B5
[8328725]
Follow-up with the pt indicated no medical intervention, serious injury, or subsequent effects from the incident. Ignition is believed to have been caused by a thermal runaway of the battery when charging was initiated. The pt had noted that the unit had been charged almost daily during the previous 18 months of usage without any issues. Investigation to date has included: review and analysis of the malfunctioning unit in conjunction with the battery manufacturer; review of design; review of verification tests, assembly procedures, and manufacturing records for the malfunctioning unit and other units. This currently appears to be an isolated event considering the large number of units manufactured without similar incidents, and circuitry/physical design intended to mitigate risks associated with the use of rechargeable batteries. The review process continues in conjunction with the battery supplier, contract manufacturer and product designer efforts to identify potential root causes and evaluate the risk of recurrence. Supplementary info will be provided if further pertinent info is identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005777056-2009-00001 |
| MDR Report Key | 1365389 |
| Report Source | 04 |
| Date Received | 2009-02-03 |
| Date of Report | 2009-02-03 |
| Date of Event | 2009-01-06 |
| Date Mfgr Received | 2009-01-06 |
| Device Manufacturer Date | 2007-09-01 |
| Date Added to Maude | 2010-05-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARK LOEWEN |
| Manufacturer Street | 2810 EMRICK BLVD. |
| Manufacturer City | BETHLEHEM PA 18020 |
| Manufacturer Country | US |
| Manufacturer Postal | 18020 |
| Manufacturer Phone | 4848211260 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROMONICS OASIS TINNITUS TREATMENT DEVICE |
| Generic Name | OASIS TINNITUS TREATMENT DEVICE |
| Product Code | KLW |
| Date Received | 2009-02-03 |
| Returned To Mfg | 2009-01-07 |
| Model Number | 110 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEUROMONICS INC. |
| Manufacturer Address | BETHLEHEM PA 18020 US 18020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-03 |