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

Model Number	2310BV
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device malfunction did not cause or contribute to the patient outcome.Initial reporter indicated the device was on and running but did not suction.We requested they return the device to sscor for evaluation and they stated they did not know where the device was.Sscor made several attempts to obtain additional information about the device with no success.Device was not returned to sscor as requested.Issue reported or root cause could not be confirmed.
Event or Problem Description
"we had a patient in cardiac arrest who had a lot of blood in his mouth.We attempted to suction using the vx-2, device was on with pump running, the battery was fully charged but we could not get it to suction.The device was returned to supply so i do not know where it is now or if it is being repaired or looked at.I can forward your contact information to someone who may be able to help you get more information on the device.I am not sure what the outcome of the patient was.I do not think he made it as he was an older gentleman.We were able to get a second suction device.The device failure delayed the ability to properly ventilate him, but i can say that it wouldn't have made a difference.Patient had a lot of past medical conditions.".

• Brand Name: SSCOR
• Common Device Name: VX-2
• Manufacturer (Section D): SSCOR INC.; 11064 randall street; sun valley CA 91352
• MDR Report Key: 8438671
• Report Number: 2022724-2019-00003
• Device Sequence Number: 13899465
• Product Code: BTA
• UDI-Device Identifier: B2452310BV0
• UDI-Public: +B2452310BV0
• Combination Product (Y/N): N
• PMA/510(K) Number: K945929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2019

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: 2310BV
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1