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

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.

Manufacturer Narrative

Suntech has evaluated the device and accessories that were returned.All information indicates the device is performing as intended.Microphones were tested and found to be within tolerance.The cuffs and patient hoses found to have no evidence of physical damage.Blood pressure readings taken using a blood pressure simulator resulted in readings that were within acceptable ranges.Reading stored within the system's memory were reviewed and did not indicate any system problems.

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.According to a conversation with broadlawns, the following sequence of events occurred.Patient checked into the stress lab at 14:00.Stress test started at 14:28.Patient became short of breath - the stress test was stopped.At 14:31, an emergency care team with special equipment and training to treat patients suffering a cardiac arrest was called.This team began attempts to resuscitate at 14:36.Patient was unresponsive at 14:55.Patient time of death was called at 15:32.Patient cause of death is undetermined.

• Brand Name: TANGO M2 STRESS BP
• Type of Device: NON-INVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
• Manufacturer (Section D): SUNTECH MEDICAL, INC,; 507 airport blvd; suite 117; morrisville NC 27560 8200
• MDR Report Key: 12294003
• MDR Text Key: 265590555
• Report Number: 1036863-2021-00001
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 10840935105732
• UDI-Public: 10840935105732
• Combination Product (y/n): N
• PMA/PMN Number: K122401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• 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 Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2130
• Device Catalogue Number: 99-0088-15
• Device Lot Number: WO-0000002964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HILL ROM SYSTEM XSCRIBE MATERIAL NUMBER 9922-019-5; HILL ROM SYSTEM XSCRIBE MATERIAL NUMBER 9922-019-5; HILL ROM SYSTEM XSCRIBE MATERIAL NUMBER 9922-019-5
• Patient Outcome(s): Death
• Patient Age: 58 YR
• Patient Weight: 98