• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SSCOR INC. SSCOR S-SCORT III Back to Search Results
Model Number 74000
Device Problem Misassembly by Users
Event Date 02/13/2019
Event Type  Malfunction  
Manufacturer Narrative

The fire department who reported this event evaluated the device on 02/14/2019 while they were reporting the issue to sscor over the phone. They stated that the issue was due to user / operator error. A hose was not properly connected causing the delay in suction. Once they properly connected the hose, the device preformed to specifications. Per the fire department, no evaluation from sscor is needed as they were able to determine the root cause of the malfunction. The device did not cause or contribute to the patient outcome. The device was not evaluated by sscor and no patient information was provided to sscor.

 
Event Description

(b)(6) fire department reported: "device powered on but had no suction, there was nothing we could have done to change the outcome of the patient. The patient died, the device had nothing to do with it. We are currently evaluating the device and the conclusion is operator error. One of the hoses was disconnected which is the reason for the failure. We cannot provide any patient information as it is against our policy".

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSSCOR
Type of DeviceS-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
maira ojeda
11064 randall st.
sun valley , CA 91352
8085044054
MDR Report Key8387952
Report Number2022724-2019-00002
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 03/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number74000
Device Catalogue Number74000
Device LOT NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/24/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 03/04/2019 Patient Sequence Number: 1
-
-