MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX CLEAR CUFF PRESSURE INFUSION; INFUSOR, PRESSURE, FOR I.V. BAGS

Model Number	MX4810
Medical Device Problem Code	Failure to Zero (1683)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.G5: 510k is blank device is exempt.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 or Problem Description
It was reported that the product would not reach to "zero".Patient involvement unknown.
Additional Manufacturer Narrative
One unit returned in original packaging.Unit received with gauge reading approximately 200mmhg with no pressure applied.Unit was tested to determine function of the gauge assembly and to test for leaks by manually pumping the bulb assembly.The gauge indicator moves as required and no leak detected, the unit returned to same location as started when pressure released.Visually confirmed unit was not on zero when returned for investigation.Unit was noted to be reading ?200mmhg on the gage with no pressure applied, review of the gauge appears to show gear assembly is aligned incorrectly.The gauge used in the mx4810 is a bourdon-tube gauge; this style of gage is sensitive when encountering a forceful impact.In these circumstances, it is possible for the gear/linkage system (attached to the bourdon tube) to fall out of proper alignment.Unit is visually inspected in production prior to release, appears issue happened after manufacturing operations.Complaint is confirmed.The product's history records (dhr) were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.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: MEDEX CLEAR CUFF PRESSURE INFUSION
• Common Device Name: INFUSOR, PRESSURE, FOR I.V. BAGS
• 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: 17194909
• Report Number: 3012307300-2023-06610
• Device Sequence Number: 5642850
• Product Code: KZD
• UDI-Device Identifier: 50351688507004
• UDI-Public: 50351688507004
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• 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: Other
• Device Model Number: MX4810
• Device Catalogue Number: MX4810
• Device Lot Number: 4383322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• 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