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

Model Number 74000

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2023

Event Type  malfunction  

Event Description

Battery failed during a cardiac arrest call.Device stopped working with in two minutes into the call.

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
• Type of Device: 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
• MDR Text Key: 319522188
• Report Number: 2022724-2023-00003
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: B2452310BV0
• UDI-Public: +B2452310BV0
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1