MAUDE Adverse Event Report: SSCOR INC. S-SCORT II

Model Number 15006

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

Device was received july 23, 2019 for evaluation.Sscor was unable to duplicate the issue reported.When tested the device met sscor specifications although the device is 15 years old and has reached its life.Outcome of the patient in unknown.Initial reporter was unable to indicate how long the device was running/suctioning properly before they turned it off.When they got back to the station, they tried to duplicate the issue and they couldn't, they stated the device powered on.The device was returned to the station on 08/13/2019.

Event Description

"had a call about a pool side drowning patient.They got the patient out and were in the process of intubating the patient.They had the s-scort ii running and suctioning, they then turned the device off because they no longer needed it and when they tried to turn it back on it would not turn on.They immediately moved the patient to the ambulance and continued suctioning with a separate device.I do not believe there was any significance to the outcome, because the delay was not long.They just had to change the course of action.I am not sure how long the device was running before they turned it off.We tried to duplicate the issue at the station and couldn't.".

• Brand Name: S-SCORT II
• Type of Device: S-SCORT II
• 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: maira ojeda ; 11064 randall st.; sun valley, CA 91352 ; 8185044054
• MDR Report Key: 8903900
• MDR Text Key: 216407997
• Report Number: 2022724-2019-00005
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/16/2019

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
• Device Operator: No Information
• Device Model Number: 15006
• Device Catalogue Number: 15006
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2004
• 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
• Patient Age: 15 YR
• Patient Weight: 54