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

Model Number	2314NB
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A scort suction unit (with new batteries installed in (b)(6) 2022 and replace battery indicator off) failed when used on a patient during a crash.
Additional Manufacturer Narrative
Sscor reached out to reporter to receive additional information.Reporter states that patient arrived in outpatients department in wycombe hospital for a routine appointment.While waiting for her appointment, patient deteriorated.Loss of consciousness and vomiting.2222 call put out.Portable suction from resuscitation trolley was not working when disconnected from the mains power supply.Alternative suction machine sourced from ent clinic in main opd to provide care for patient.Patient transferred to cardiac and stroke receiving unit (csru).The fault was reported to medical engineering to review and replace the battery.Medical engineering ran functional test on the device and confirmed the battery had failed.A replacement battery was installed and device returned to use after functional testing.The failed battery was installed 18 months earlier.Per reporter device malfunction did not contribute to patient outcome as an alternative device was used.Reported has stated that battery has been discarded and lot # could not be provided or return battery for evaluation.Without a lot number for the battery in question, sscor could not confirm how old the battery was.As a courtesy sscor will issue a replacement battery.Sscor has advised reporter to replace battery every 3 years and perform battery tests as stated in product manual.

• Brand Name: SSCOR IINC
• 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: 17761283
• Report Number: 2022724-2023-00004
• Device Sequence Number: 15246885
• Product Code: BTA
• UDI-Device Identifier: B2452314NB1
• UDI-Public: +B2452314NB1
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/15/2023

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: 2314NB
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2010
• 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: Female