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

Model Number	74000
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was manufactured and shipped 12/16/2016, it was not put into service until november 2017.As stated by the user the device sat in the box for months before it was put into service.Sscor places a large yellow label on each device box that indicates the battery recharge date.This device should have been charged no later than june 16, 2017 to assure the battery operates at its maximum efficiency.Sscor's labeling clearly indicates to keep the device on charge at all times when the unit is not in use.Failing to charge a battery for an extended period of time will cause the battery to go into deep discharge which is the cause of this malfunction.The only way to assure the battery has a functional capacity, is to perform the battery check suggested on the sscor manual.
Event or Problem Description
Per customer (user): "the unit in question was used during cardiac arrest and failed when suction was attempted.The failure did not have an impact on the outcome of the patient.The unit was just purchased a few months ago and wasn't placed into service until the middle of (b)(6).The unit sat in the closed box until the ambulance inspection with the state.I have already purchased a replacement battery and the unit is already back in service and functioning fine.At this time we will not be submitting any additional information as the battery failure had nothing to do with the patients outcome.".

• Brand Name: SSCOR SUCTION DEVICES
• Common Device Name: S-SCORT III
• Manufacturer (Section D): SSCOR, INC.; 11064 randall st.; sun valley CA 91352
• MDR Report Key: 7318170
• Report Number: 2022724-2018-00001
• Device Sequence Number: 19362105
• Product Code: JCX
• UDI-Device Identifier: B245740000
• UDI-Public: +B245740000
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K791210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2018

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: 74000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1