MAUDE Adverse Event Report: NULL MEDEX TRANSTAR CABLES; CABLE, PHYSIOCONTROL MONITOR

Catalog Number MX981-03

Device Problem Output Problem (3005)

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

Event Date 01/31/2022

Event Type  malfunction  

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).D3 manufacturer name: supplier: (b)(4).D4 (udi), g2 and g5 are unknown; no further information was provided.This is a supplied item.A device history record (dhr) review was not applicable in this case because the component is not evaluated or tested in any way during the manufacturing process at this manufacturer; and the device manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.The device was returned in used condition.Visual inspection of cable and connectors: one cable has a crack in the outer insulation.There was no external damage visible on the remaining 7 cables.The reported problems could not be tested due to missing test equipment; the fault cannot be verified.The samples will be investigated by the supplier.

Event Description

It was reported the device had 2nd derivative unstable and values not usable.No patient injury occurred.

• Brand Name: MEDEX TRANSTAR CABLES
• Type of Device: CABLE, PHYSIOCONTROL MONITOR
• Manufacturer (Section G): NULL
• MDR Report Key: 16917842
• MDR Text Key: 315066877
• Report Number: 3012307300-2023-05625
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX981-03
• Device Lot Number: 4919V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1