MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX LOGICAL TRANSDUCER MOUNTING PLATE; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number MX960

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Zero (1683); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2023

Event Type  malfunction  

Manufacturer Narrative

E1 - phone number: (b)(6).H3 - other: device has not been returned to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the "pressure plate zero is not within 100±3.The p1 p2 p3 p4 value shows 196-197.The port is not in good contact and cannot be connected.The pressure value is displayed as 1067-1066; which is marked as 100±3." there was no patient involvement reported and no harm/adverse event reported.

• Brand Name: MEDEX LOGICAL TRANSDUCER MOUNTING PLATE
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19119270
• MDR Text Key: 340834702
• Report Number: 1526863-2024-00024
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 10351688502988
• UDI-Public: (01)10351688502988(17)330820(10)4422966
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K961404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MX960
• Device Lot Number: 4422966
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1