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	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer claim could not be confirmed as device was not returned for evaluation.Sscor reached out to reported to receive additional information.Reported stated that they were into a cardiac arrest call and device died during the emergency call.Reported states that devices were not being serviced as often as they should.Sscor has issued replacement battery and has advised reported to perform battery maintenance as stated on device instruction manual.After battery was shipped, sscor tech support reached out to reporter and reporter stated that replacing the battery has resolved their issue.
Event or Problem Description
Battery failure, unit did not hold a charge.

• 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: 19337720
• Report Number: 2022724-2024-00005
• Device Sequence Number: 15651461
• Product Code: BTA
• UDI-Device Identifier: B2452310BV0
• UDI-Public: +B2452310BV0
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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: C10394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2022
• 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
• Patient Sex: Unknown