MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC - SINGAPORE DTX SAFEDRAW KITS.GABARITH¿; COMPUTER, BLOOD-PRESSURE

Catalog Number	688420/D
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and three similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.
Event or Problem Description
The complaint alleges that a patient had repeated high blood pressure measurements that could not be confirmed with non-invasive measurement techniques.The discrepancy was as high as 80 mmhg.A side comparison with non-invasive measurement resulted in values of around 120 mmhg systolic.Exchanged the set and the values normalized.

• Brand Name: DTX SAFEDRAW KITS.GABARITH¿
• Common Device Name: COMPUTER, BLOOD-PRESSURE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC - SINGAPORE; 198 yishun ave7; singapore 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC - SINGAPORE; 198 yishun ave7; singapore 76892 6; SN 768926
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 21318387
• Report Number: 8020616-2025-00003
• Device Sequence Number: 20848765
• Product Code: DSK
• UDI-Device Identifier: 00884450654538
• UDI-Public: 884450654538
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 688420/D
• Device Lot Number: C2978868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown