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

Model Number	MX960
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer cannot return to zero, excessive drift, and cannot read data.No patient injury.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#617147.No problems or issues were identified during this device history record review.Visual and functional tests were performed.Ten units returned for investigation.Each unit had adhesive tape or sticker applied to the unit.Each unit was visually inspected under 10x magnification.Five units were found to be missing a plated insert from the connector.With the pin insert missing the mating connector pin is too small to contact the connector pins on the transducer so no connection or intermittent connection is possible.The remaining 5 units appear to have no physical damage.Ten units functional tested per internal test.Five failed functional testing, all complaints from same end user tested during one test run and included the units missing insert or pins, four of these units failed due to the insert or pin missing.One failed unit was opened and found to have a cracked sensor causing failure.The remaining four units are unable to duplicate as returned.Unable to determine the amount of usage prior to the inserts being pulled out of the connector although each unit appears to have been used prior to issue detection.Confirmed issues as noted in complaint description on 5 of the units.One unit has an intermittent connection due to missing inserts.Four units unable to duplicate any failure as returned.The root cause of this complaint cannot be determined.
Additional Manufacturer Narrative
Other, other text: corrected data: b1, corrected data: corrected data: b1-product problem.

• Brand Name: MEDEX LOGICAL TRANSDUCERS
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16875660
• Report Number: 3012307300-2023-05141
• Device Sequence Number: 14910498
• Product Code: DRS
• UDI-Device Identifier: 10351688502988
• UDI-Public: 10351688502988
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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 Model Number: MX960
• Device Catalogue Number: MX960
• Device Lot Number: 4027696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown