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

Lot Number 4093897

Device Problem Calibration Problem (2890)

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

Event Date 01/10/2020

Event Type  malfunction  

Event Description

It was reported that the device is presenting with unstable error.Gas calibration fails with the agent.No patient injury was reported.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation with a photo provided.Visual and functional testing were performed.Visual inspection found no visual damage.Functional testing found that splotches on the coating of the device and were most likely occurred during the coating process.The root cause of the reported issue was found to be th splotches on the coating.D5 operator of device is patient/consumer.No information is provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

• 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: 15326388
• MDR Text Key: 305366049
• Report Number: 3012307300-2022-16900
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• 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: Lay User/Patient
• Device Lot Number: 4093897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1