MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-04 for SSCOR 2310BV manufactured by Sscor Inc..
[134899757]
The fire department was not following the recommended battery maintenance procedures as described in the operations manual. Device failure did not have an adverse impact on the patient. Sscor attempted to obtain additional patient, event and device information from the initial reporter on various occasions and calls were not returned.
Patient Sequence No: 1, Text Type: N, H10
[134899758]
"device failed during an emergency situation. Patient was choking, the device stopped working 3 minutes into the suction procedure. We were able to stabilize the patient and no harm was caused. The suction unit was included in an ambulance that was purchased in 2016. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022724-2019-00001 |
| MDR Report Key | 8301848 |
| Date Received | 2019-02-04 |
| Date of Report | 2019-01-31 |
| Date Mfgr Received | 2019-01-03 |
| Device Manufacturer Date | 2016-06-28 |
| Date Added to Maude | 2019-02-04 |
| 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 | 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 | 2019-02-04 |
| Model Number | 2310BV |
| Catalog Number | 2310BV |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-02-04 |