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)
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) ambulance services reported that a vehicle fell on adult male in a garage, patient had emesis in airway, suction unit blinked red when attempting to be used, back up suction unit was used instead.Ultimately the suction device did not contribute to the patient outcome.When asked if they would send the device in for eval, they required a loaner device.Replacement battery was issued and this resolved 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 ; 8185044054
• MDR Report Key: 23594851
• Report Number: 2022724-2025-00002
• Device Sequence Number: 13067140
• Product Code: BTA
• UDI-Device Identifier: B2452310BV0
• UDI-Public: +B2452310BV0
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K945929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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: Health Professional
• Device Model Number: 2310BV
• Device Catalogue Number: 2310BV
• 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: 10/16/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2025
• 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: Male