FDA.reportPublic FDA data

MAUDE MDR 6851940

MDR report key
6851940
Report number
2022724-2017-00001
Event key
0
Event type
3
Date of event
2017-04-06
Date received
2017-09-08
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. MAIRA OJEDA
Address
11064 RANDALL STREET SUN VALLEY CA 91352 US
Phone
818-818-8185
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SSCORVX-2SSCOR, INC.BTA2310BV2310BVN/AN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-0801. D

Event Narratives#

N

Patient 1

ON APRIL 20, 2017 SSCOR RECEIVED AN EMAIL FROM (B)(6), LOGISTICS OFFICER 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 12 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 8 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.

D

Patient 1

PARAMEDICS WERE CALLED TO THE (B)(6) DUE TO A POSSIBLE DROWNING. UPON ARRIVAL THE PARAMEDICS FOUND A (B)(6) FEMALE LAYING ON THE SIDE OF THE INDOOR POOL WITH COMPRESSIONS AND ASSISTED VENTILATIONS WITH OPA AND BVM BEING PERFORMED BY THE (B)(6) FIRE DEPARTMENT. ACLS WAS INITIATED BY THE PARAMEDICS, HOWEVER THE PATIENT WAS UNRESPONSIVE, THE CONDITION OF THE PATIENT REPORTED UPON ARRIVAL WAS "DEAD". THE CHEST AND LUNG FINDINGS WERE ABSENT AS WAS A PULSE. ADDITIONALLY THE BILATERAL EYE FINDINGS WERE REPORTED AS FIXED AND DILATED. THE PARAMEDICS ATTEMPTED TO SUCTION THE PATIENT USING A SSCOR SUCTION DEVICE AND THE DEVICE WOULD NOT OPERATE. THERE WAS A QUICK RESPONSE VEHICLE (QRV) PRESENT AND THEY WERE ABLE TO USE THE SUCTION DEVICE FROM THE QRV TO TREAT THE PATIENT.