MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-09-08 for SSCOR 2310BV manufactured by Sscor, Inc.
[85371918]
On (b)(6) 2017 sscor received an email from (b)(6), (b)(6) of (b)(6) ems. The email indicated in the past week the department had two sscor vx-2 (model 2310bv) suction units stop working during patient care situations. After the email was received sscor followed up with (b)(6) to gather additional information. The initial indications were the device stopped working because the internal battery in the suction device had lost capacity. Sscor requested the department check all of the batteries in their devices by conducting the battery test as described in the instructions for use for the devices. Additionally, sscor sent out a total of (b)(4) new replacement batteries for all the sscor suction units owned by the department as a precautionary measure. On (b)(6) 2017 the department reported they found that (b)(4) of the devices had batteries with low capacity. They were able to replace these low capacity batteries with the replacement batteries sscor sent out. Sscor also discussed the battery care and maintenance procedures as described in the operations manual with the department. The department was not following the recommended battery maintenance procedures. After the discussion the department agreed to update their internal protocols and follow the battery care and maintenance procedures as described in the operations manual for the devices.
Patient Sequence No: 1, Text Type: N, H10
[85371919]
Paramedics were called to aid a patient with breathing problems. The paramedics arrived to find the patient unresponsive, pulse-less and apneic. Additionally the patients pupils were fixed and non-reactive and motor skills were found to be flaccid. The paramedics initiated cpr activities and attempted to suction the patient at the scene using a sscor suction device. The device would not operate at that time. The patient was transported to the vehicle and the suction unit was installed into its charging / retention bracket at which time the device operated to specifications as it was being powered by the vehicle battery. The patient was transported to the hospital where he was pronounced dead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022724-2017-00002 |
| MDR Report Key | 6851973 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-09-08 |
| Date of Report | 2017-05-17 |
| Date of Event | 2017-04-19 |
| Date Mfgr Received | 2017-04-20 |
| Device Manufacturer Date | 2011-12-30 |
| Date Added to Maude | 2017-09-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 913522621 |
| Manufacturer Country | US |
| Manufacturer Postal | 913522621 |
| Manufacturer Phone | 8185044054 |
| Manufacturer G1 | SSCOR, INC. |
| Manufacturer Street | 11064 RANDALL STREET |
| Manufacturer City | SUN VALLEY CA 913522621 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 913522621 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SSCOR |
| Generic Name | VX-2 |
| Product Code | BTA |
| Date Received | 2017-09-08 |
| Model Number | 2310BV |
| Catalog Number | 2310BV |
| Lot Number | N/A |
| Operator | PARAMEDIC |
| Device Availability | Y |
| 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 913522621 US 913522621 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-09-08 |