MAUDE Adverse Event Report: SSCOR INC. SSCOR; SSCORT III

Model Number	74000
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reported stated that device model 74000 failed to suction during an attempt to suction a cardiac arrest patient.After device case was opened it was determined tah fitting that connects from pump to elbow was broken.No additional information was required.

• Brand Name: SSCOR
• Common Device Name: SSCORT III
• Manufacturer (Section D): SSCOR INC.; 11064 randall st.; sun valley CA 91352
• Manufacturer (Section G): SSCOR INC.; 11064 randall st.; sun valley 91352
• Manufacturer Contact: marisela nolasco ; 11064 randall st.; sun valley, CA 91352 ; 8185044054
• MDR Report Key: 20868389
• Report Number: 2022724-2024-00007
• Device Sequence Number: 20796121
• Product Code: JCX
• UDI-Device Identifier: B245740000
• UDI-Public: +B245740000
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K791210
• 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): 12/06/2024

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: 74000
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2021
• 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