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U.S. Department of Health and Human Services

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

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SSCOR INC. S-SCORT II Back to Search Results
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.".
 
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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 Key8903900
MDR Text Key216407997
Report Number2022724-2019-00005
Device Sequence Number1
Product Code JCX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K791210
Number of Events Reported1
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 Number15006
Device Catalogue Number15006
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2019
Initial Date Manufacturer Received 07/19/2019
Initial Date FDA Received08/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/04/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age15 YR
Patient Weight54
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