MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-17 for TYVASO INHALATION SYSTEM ON-100HPA * manufactured by Nebu-tec Med Produkte.
[21017709]
A pt reported through (b)(6) that when he opened his bag with the pump and supplies, the battery was on fire and smoke was coming out of the bag. Eval summary: both devices and the battery pack were returned for investigation. The battery pack exhibited plastic melting on the right side of the clip. The investigation showed that based on the damage of the connector, the battery pack was "short circuited" at the output connector. Also, based on the connector damage and orientation on the case, the condition did not occur when connected to the device. The coaxial power plug melted, suggesting it was shorted out either externally or from within the molded housing. Both returned devices showed no burn marks and powered up normally with ac power adapter. Internal investigation continues as part of the opened corrective and preventive action plan. The device history records were reviewed and no evidence was found to indicate non-conformance to the mfg and/or design specs. Device manufacture date: 9/2009. Consumer reporter details withheld usa.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022616 |
| MDR Report Key | 2299588 |
| Date Received | 2011-10-17 |
| Date of Report | 2011-10-06 |
| Date Added to Maude | 2011-10-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TYVASO INHALATION SYSTEM |
| Generic Name | NEBULIZER |
| Product Code | CAF |
| Date Received | 2011-10-17 |
| Returned To Mfg | 2011-03-23 |
| Model Number | ON-100HPA |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEBU-TEC MED PRODUKTE |
| Manufacturer Address | * ELSENFELD 63820 GM 63820 |
| Brand Name | TYVASO INHALATION SYSTEM |
| Generic Name | NEBULIZER |
| Product Code | EPN |
| Date Received | 2011-10-17 |
| Returned To Mfg | 2011-03-23 |
| Model Number | ON-100/7 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | NEBU-TEC MED PRODUKTE |
| Manufacturer Address | ELSENFELD 63820 GM 63820 |
| Brand Name | TYVASO INHALATION SYSTEM |
| Generic Name | NEBULIZER |
| Product Code | EPN |
| Date Received | 2011-10-17 |
| Returned To Mfg | 2011-03-23 |
| Model Number | ON-100/7 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | NEBU-TEC MED PRODUKTE |
| Manufacturer Address | ELSENFELD 63820 GM 63820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-17 |