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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNTECH MEDICAL, INC. OSCAR 2, 250D SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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SUNTECH MEDICAL, INC. OSCAR 2, 250D SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number 250D
Device Problems Overheating of Device (1437); Electrical Shorting (2926)
Patient Problem No Patient Involvement (2645)
Event Date 11/27/2019
Event Type  malfunction  
Manufacturer Narrative
Short circuit was confirmed. If the batteries are installed in the reverse polarity, within two to three minutes, depending on the type of batteries used, the temperature of the battery and associated components such as the battery contacts, can reach temperatures in excess of 140 degrees f. Burns to fingers and hands are possible for the patient and/or health care provider.
 
Event Description
Customer reporting this unit had an overheating at the battery sight and that it melted when the batteries were installed and no longer works.
 
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Brand NameOSCAR 2, 250D
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
SUNTECH MEDICAL, INC.
507 airport blvd, suite 117
morrisville, nc
Manufacturer (Section G)
SUNTECH MEDICAL, INC.
507 airport blvd, suite 117
morrisville, nc
Manufacturer Contact
charles setzer
507 airport blvd, suite 117
morrisville, nc 
MDR Report Key9723832
MDR Text Key193400089
Report Number1036863-2020-00002
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeDR
PMA/PMN Number
K151500
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial
Report Date 12/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number250D
Device Catalogue Number99-0233-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction Number84531

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