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

Model Number	2310BV
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025 (b)(6) fire dept.Reported that device sn (b)(6) died at the end of an cardiac arrest call.Device died with in 30 minutes into the call as far as to when volunteer went to do intubation.Reported stated that device is always kept on charge.Sscor issued a replacement battery to resolve their issue.

• Brand Name: SSCOR, INC
• Common Device Name: SSCOR VX-2
• Manufacturer (Section D): SSCOR INC.; 2125 n. madera rd. unit c; simi valley CA 93065
• Manufacturer (Section G): SSCOR INC.; 2125 n. madera rd. unit c; simi valley CA 93065
• Manufacturer Contact: marisela nolasco ; 2125 n. madera rd. unit c; simi valley, CA 93065 ; 8188054054
• MDR Report Key: 21684453
• Report Number: 2022724-2025-00001
• Device Sequence Number: 9234382
• Product Code: BTA
• UDI-Device Identifier: B2452310BV0
• UDI-Public: +B2452310BV0
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/24/2025

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: Other
• Device Model Number: 2310BV
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2023
• 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