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

Model Number	MX960
Medical Device Problem Code	Explosion (4006)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device exploded during the procedure.This led to the patients blood pressure not being able to be checked at the beginning of the examination.A different transducer was used to be able to monitor the patient and get them hemodynamically stable.No harm to the patient came from this event.
Additional Manufacturer Narrative
D4: expiration date and h4: manufacture date are unknown, invalid lot number provided by the customer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Additional Manufacturer Narrative
Other text: additional information is provided in d.10., h.2., h.3., and h.6.One (1) sample was received for evaluation without its original packaging, inside a plastic bag in decontaminated conditions.During the visual inspection it is observed unit received with diaphragm ruptured and most of the dialectric gel missing from the transducer.The number 9 is written on the back of the transducer.The complaint is confirmed.Manual electrical continuity tested on unit and met input and output specifications.Due to age unable to determine amount of use prior to diaphragm failure.Possible cause was diaphragm was damaged by insertion of the mating transducer cartridge.A device history record (dhr) review was not conducted, based upon review of the information provided by the customer, as it does not indicate a problem with the initial manufacture or prior repair of the device.For all enquiries or follow-up questions related to the record, do not use (b)(6) located in sections g.1., please direct those to the following: (b)(6).

• Brand Name: LOGICAL PRESSURE MONITORING SYSTEM
• 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: 16857165
• Report Number: 3012307300-2023-04943
• Device Sequence Number: 14268998
• Product Code: DRS
• UDI-Device Identifier: 10351688502988
• UDI-Public: 10351688502988
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K961404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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: AV346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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