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

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.

• Brand Name: OSCAR 2, 250D
• Type of Device: SYSTEM, 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 Key: 9723832
• MDR Text Key: 193400089
• Report Number: 1036863-2020-00002
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: DR
• PMA/PMN Number: K151500
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 250D
• Device Catalogue Number: 99-0233-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 84531
• Patient Sequence Number: 1