MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2018-10-30 for INCOURAGE SYSTEM ICS-1M-US-A 500055-000 manufactured by Respiratory Technologies Inc..
[125469335]
Patient had been using vest therapy successfully for 6 months, then was hospitalized for an unrelated condition. After being discharged, patient resumed vest therapy and after three sessions, patient developed shortness of breath. Patient was taken to the er and found to have a pneumothorax on the left and was admitted. Spouse states that hospital physicians do not know cause of pneumothorax. Followed up with patient's pulmonologist who said that at this time they feel the pneumothorax is unrelated to vest use, however they cannot make an absolute determination. Results of manufacturer testing of returned device: the device was found to be operating normally within defined specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004961434-2018-00002 |
| MDR Report Key | 8019124 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-02 |
| Date of Event | 2018-09-24 |
| Date Mfgr Received | 2018-10-02 |
| Device Manufacturer Date | 2018-01-25 |
| Date Added to Maude | 2018-10-30 |
| 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 | MR. DAVID WESTLIN |
| Manufacturer Street | 2896 CENTRE POINTE DRIVE |
| Manufacturer City | ST PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6513483837 |
| Manufacturer G1 | RESPIRATORY TECHNOLOGIES INC. |
| Manufacturer Street | 2896 CENTRE POINTE DRIVE |
| Manufacturer City | ST PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INCOURAGE SYSTEM |
| Generic Name | PULSATING VEST THERAPY |
| Product Code | BYI |
| Date Received | 2018-10-30 |
| Returned To Mfg | 2018-10-19 |
| Model Number | ICS-1M-US-A |
| Catalog Number | 500055-000 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRATORY TECHNOLOGIES INC. |
| Manufacturer Address | 2896 CENTRE POINTE DRIVE ST PAUL MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-10-30 |