MAUDE Adverse Event Report: SSCOR INC. SSCOR INC; S-SCORT III

Model Number	74000
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Battery failed during a cardiac arrest call.Device stopped working with in two minutes into the call.
Additional Manufacturer Narrative
Sscor reached out to initial reporter to obtain additional information.Initial reporter stated that they received a call for a patient that was on cardiac arrest, coughing blood and had a compromised airway.Device died with in two minutes into the call, a second aspirator was used to suction.Reporter stated that once they were back at the station they noticed the battery was hot.The battery was inspected and it was not worn or damaged, the battery seemed new.Once the battery cooled off device started working properly.Per initial reporter battery malfunction did not cause or contribute to outcome of patient device was not returned for evaluation.Sscor has requested reporter to return non-conforming battery for evaluation.Once battery evaluation is concluded an additional report will be submitted.Sscor has issued a replacement battery and advised reporter to perform battery tests as stated in product manual.

• Brand Name: SSCOR INC
• Common Device Name: S-SCORT III
• 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: 17322039
• Report Number: 2022724-2023-00003
• Device Sequence Number: 17729188
• Product Code: JCX
• UDI-Device Identifier: B2452310BV0
• UDI-Public: +B2452310BV0
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Distributor
• 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: Health Professional
• Device Model Number: 74000
• 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: 06/14/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2021
• 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