MAUDE Adverse Event Report: SSCOR INC SSCOR INC; SSCOR VX-2

Model Number	2310BV
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sscor reached out to initial reporter to obtain additional information.Initial reporter states the unit works to specification.However, when responding to a cardiac arrest, the device did not run from battery power.Initial reporter checked with team if battery was checked and discovered that it was user error as battery was checked while device was on bracket.Battery malfunction did not cause or contribute to outcome of patient.Battery nor device have been returned for evaluation.Sscor has advised customer to perform battery tests as stated in product manual and has issued replacement battery for device.
Event or Problem Description
Medic unit was responding to a call for cardiac problem.During intubation device was unable to suction and medic unit had to wait for a working unit.

• Brand Name: SSCOR INC
• Common Device Name: SSCOR VX-2
• Manufacturer (Section D): SSCOR INC; 11064 randall st.; sun valley CA 91352
• Manufacturer (Section G): SSCOR INC; 11064 randall st; sun valley CA 91352
• Manufacturer Contact: marisela nolasco ; 11064 randall st; sun valley, CA 91352 ; 8185044054
• MDR Report Key: 16230242
• Report Number: 2022724-2022-00002
• Device Sequence Number: 5351650
• Product Code: BTA
• UDI-Device Identifier: B2452310BV0
• UDI-Public: +B2452310BV0
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2310BV
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 130 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White