MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-30 for SVS-JC-V7 UNKNOWN manufactured by Spiration.
[112841192]
The pneumothorax was deemed possibly related to the valve. No conclusion about the device can be made because the product was not returned for investigation and work order review did not indicate any issues contributing to the event. However, pneumonia and pneumothorax are known potential complications with the spiration valve system.
Patient Sequence No: 1, Text Type: N, H10
[112841193]
[auto-translated] subjects: (b)(4), (b)(6) male; valve detention day: (b)(6) 2016; valve placement site: lower right lobe, 5; valve withdrawal date: (b)(6) 2018; pneumonia was repeated from (b)(6). Shadows remained in the site where the valve was placed, and all valves were removed. Pneumothorax was accompanied after removing the valve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004450998-2018-00005 |
| MDR Report Key | 7653907 |
| Date Received | 2018-06-30 |
| Date of Report | 2018-06-30 |
| Date of Event | 2018-05-23 |
| Date Mfgr Received | 2018-05-31 |
| Device Manufacturer Date | 2015-04-16 |
| Date Added to Maude | 2018-06-30 |
| 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 | CYNDY ADAMS |
| Manufacturer Street | 6675 185TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4256365450 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SVS-JC-V7 |
| Generic Name | ONE WAY AIR LEAK VALVE |
| Product Code | OAZ |
| Date Received | 2018-06-30 |
| Model Number | UNKNOWN |
| Lot Number | W00307-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPIRATION |
| Manufacturer Address | 6675 185TH AVENUE NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-30 |