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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 01/06/2020
Event Type  malfunction  
Event Description
It was reported that the secretary of the center put batteries that were included in the original packaging in the device and start the device. The device was then given to the patient, turned on and a measurement was performed to verify proper functioning of the device. A few moment after, it was realized that the device was hot and batteries were removed immediately. Batteries were hot. As no damage was observed on the device, the secretary put other batteries (different from original packaging) and proper functioning of the device was observed. There is no indication about batteries position when the event occurred, the secretary do not know if batteries were appropriately inserted or not.
 
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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 Key9730018
MDR Text Key198539062
Report Number1036863-2020-00003
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeFR
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 01/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2020
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? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2020
Was Device Evaluated by Manufacturer? No
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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