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	06/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Battery failed during a cardiac arrest call.Unit will turn on but there was not enough suction.Sscort iii was used as back up.
Additional Manufacturer Narrative
Sscor reached out to initial reporter to obtain additional information.Initial reporter stated that they received a call for a 68 year old male in cardiac arrest and device did not have enough suction.When device was taken off the bracket it had a full green led, but then the orange and red led light started blinking.Back up device (sscort iii) was used to suction.Reporter also stated that battery has not been replaced since device was purchased on 02/22/2019.Per initial reporter battery malfunction did not cause or contribute to outcome of patient.Device was not returned for evaluation.Battery malfunction is typically due to poor battery maintenance.Sscor has advised reporter to replace battery every 3 years and perform battery tests as stated in product manual.Sscor has issued a replacement battery.

• 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: 17321817
• Report Number: 2022724-2023-00002
• Device Sequence Number: 20464127
• Product Code: BTA
• UDI-Device Identifier: B2452310BV0
• UDI-Public: +B2452310BV0
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2019
• 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 Age: 68 YR
• Patient Sex: Male