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	04/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sscor reached out to initial reported to obtain additional information.Initial reported stated that during a cardiac arrest call the paramedic called him to help troubleshoot a device that was failing suction and shutting off with in two minutes, but was unable to help trouble shoot as device kept shutting off.When the ambulance came back the device was placed on the cradle and charged for 5-6 hours.Device was turned on and mimicked suction but device shut off within 40 seconds.Other devices were checked and those had no issues.Per initial reported battery malfunction did not cause or contribute to outcome of patient.Device was returned for evaluation.Sscor tested device to sscor specifications and confirmed that device malfunction was to low battery capacity.Sscor has advised customer to perform battery tests as stated in product manual and has issued a replacement device.
Event or Problem Description
During a cardiac arrest call device turned on but died with in 20 seconds.

• Brand Name: SSCOR INC
• Common Device Name: SSCOR VX-2
• Manufacturer (Section D): SSCOR INC; 11064 randall st; sun valley CA 90352
• 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: 16967314
• Report Number: 2022724-2023-00001
• Device Sequence Number: 14847918
• Product Code: BTA
• UDI-Device Identifier: B2452310BV0
• UDI-Public: +B2452310BV0
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/18/2023

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2021
• 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