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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNTECH MEDICAL, INC, TANGO M2 STRESS BP NON-INVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM

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SUNTECH MEDICAL, INC, TANGO M2 STRESS BP NON-INVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM Back to Search Results
Model Number 2130
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 06/28/2021
Event Type  Death  
Manufacturer Narrative
Hill-rom, the manufacturer of the stress system, verbally reported to suntech that a patient had died while undergoing a stress test. Suntech medical has not confirmed this event nor the details surrounding the event (e. G. Patient demographic information, cause of death, etc. ) despite contacting hill rom and the facility multiple times. Except for initial information identifying the tango m2 (serial number, model number, etc), we have been unable to determine how the tango was used during and after the stress test and any patient information. Suntech has contacted hill rom 4 times and the clinic 3 times and in each case it was determined a different person could better answer suntech's questions. Suntech has identified and is working to contact these additional individuals at hill rom and the clinic.
 
Event Description
Hill rom reported to suntech that a patient died while undergoing a stress test. The hill rom stress test system normally includes a suntech tango m2 device. Patient cause of death and how the tango device was used has not been confirmed.
 
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Brand NameTANGO M2 STRESS BP
Type of DeviceNON-INVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
Manufacturer (Section D)
SUNTECH MEDICAL, INC,
507 airport blvd
suite 117
morrisville NC 27560 8200
Manufacturer (Section G)
SUNTECH MEDICAL, INC.
507 airport blvd, suite 117
morrisville NC 27560 8200
Manufacturer Contact
charles setzer
507 airport blvd, suite 117
morrisville, NC 27560-8200
9196542300
MDR Report Key12294003
MDR Text Key265590555
Report Number1036863-2021-00001
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2130
Device Catalogue Number99-0088-15
Device Lot NumberWO-0000002964
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/09/2021 Patient Sequence Number: 1
Treatment
HILL ROM SYSTEM XSCRIBE MATERIAL NUMBER 9922-019-5
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