MAUDE Adverse Event Report: ST PAUL PATIENT MONITORING ACCESSORIES; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DE

Catalog Number 71840A1

Device Problem Calibration Problem (2890)

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

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The product was received for investigation both visual and functional testing were performed.The reported issue was confirmed.The reported issue has been link to the coating.It is unknown whether the issue was caused by the user's application or a manufacturing process.(udi) is unknown.No information is provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

Event Description

It was reported that the device was presenting with unstable error.This resulted in being unable to perform gas calibration.No patient injury was reported.

• Brand Name: PATIENT MONITORING ACCESSORIES
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 6-chome nagareyama city; minneapolis, MN 55442
• MDR Report Key: 15326558
• MDR Text Key: 305346015
• Report Number: 3012307300-2022-16914
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K982279
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2022

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
• Device Operator: Other
• Device Catalogue Number: 71840A1
• Device Lot Number: 4094082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1