MAUDE Adverse Event Report: SSCOR INC. SSCOR INC; SSCOR DUET

Model Number	2314
Medical Device Problem Code	Failure to Run on Battery (1466)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sscor reached out to reporter to obtain additional information, reporter stated that on 4/4 general hospital in grand junction colorado had a call for a patient that was on oncology therapy that went into cardiac arrest.Reporter stated that the device was on the crash cart, but once disconnected from the wall it will no power on.An alternate device was used.Customer was advised that devices are to be maintained on charge when not in use per product manual.Reporter stated that device was not placed on charge for the last 4 or 5 months and it was just place into service (b)(6) 2024.A replacement battery was sent to customer, but customer issue was not resolved.After trouble shooting device with tech support it was determined that the failure was due to a non conforming pc board.Customer was sent a replacement pc board.The customer confirmed that replacing their 80540 board solved the issue with the device failing to power on.
Event or Problem Description
2314 failed to operate on battery power.

• Brand Name: SSCOR INC
• Common Device Name: SSCOR DUET
• 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: 19281296
• Report Number: 2022724-2024-00002
• Device Sequence Number: 6320363
• Product Code: BTA
• UDI-Device Identifier: B24523140
• UDI-Public: +B24523140
• 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: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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: Other
• Device Model Number: 2314
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2023
• 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: Prefer Not To Disclose