MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-03-20 for SSCOR 2310BV manufactured by Sscor Inc..
[139441606]
Device malfunction did not cause or contribute to the patient outcome. Initial reporter indicated the device was on and running but did not suction. We requested they return the device to sscor for evaluation and they stated they did not know where the device was. Sscor made several attempts to obtain additional information about the device with no success. Device was not returned to sscor as requested. Issue reported or root cause could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[139441607]
"we had a patient in cardiac arrest who had a lot of blood in his mouth. We attempted to suction using the vx-2, device was on with pump running, the battery was fully charged but we could not get it to suction. The device was returned to supply so i do not know where it is now or if it is being repaired or looked at. I can forward your contact information to someone who may be able to help you get more information on the device. I am not sure what the outcome of the patient was. I do not think he made it as he was an older gentleman. We were able to get a second suction device. The device failure delayed the ability to properly ventilate him, but i can say that it wouldn't have made a difference. Patient had a lot of past medical conditions. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022724-2019-00003 |
| MDR Report Key | 8438671 |
| Report Source | OTHER |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-02-19 |
| Device Manufacturer Date | 2017-02-27 |
| Date Added to Maude | 2019-03-20 |
| 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 | MS. MAIRA OJEDA |
| Manufacturer Street | 11064 RANDALL STREET |
| Manufacturer City | SUN VALLEY CA 91352 |
| Manufacturer Country | US |
| Manufacturer Postal | 91352 |
| Manufacturer Phone | 8185044054 |
| Manufacturer G1 | SSCOR INC. |
| Manufacturer Street | 11064 RANDALL STREET |
| Manufacturer City | SUN VALLEY CA 91352 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91352 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SSCOR |
| Generic Name | VX-2 |
| Product Code | BTA |
| Date Received | 2019-03-20 |
| Model Number | 2310BV |
| Catalog Number | 2310BV |
| Lot Number | N/A |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SSCOR INC. |
| Manufacturer Address | 11064 RANDALL STREET SUN VALLEY CA 91352 US 91352 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-20 |