MAUDE Adverse Event Report: COVIDIEN 31.1914.21 H914SG ECG ELDIAGF448X34MMX30; ELECTRODE, ELECTROCARDIOGRAPH

Model Number 31.1914.21

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.  if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the electrode caused drifts, artifact, and an inaccurate signal.Various cables and devices had been tried.There was no patient harm.

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The picture of ecg reading was visually checked and shows ecg readings with minor noises.Twenty-nine (29) electrodes were returned for the investigation.For product analysis, the following tests were performed: ¿ evaluation according to inspection procedure for release control was performed as the results, requirement was fulfilled, all parts existing, nothing has damaged.¿ electrical parameters according to procedure was performed as a result, the requirement was fulfilled.Electrical parameters were within limits.As the samples returned did not show any issues, it is not possible to determine the true root cause.The most probable root cause of the tracing issues could be caused by the used adapters, cables or by impedance limit of the used monitors.A corrective action is not applicable at this time.This complaint will be recorded for tracking and trending purposes.

• Brand Name: 31.1914.21 H914SG ECG ELDIAGF448X34MMX30
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN; quedlinburger strasse 39a; halberstadt D3882 0; GM D38820
• MDR Report Key: 10659025
• MDR Text Key: 213074865
• Report Number: 9710060-2020-00203
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2021

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: No Information
• Device Model Number: 31.1914.21
• Device Catalogue Number: 31.1914.21
• Device Lot Number: 20182C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 09/29/2020; 09/29/2020
• Supplement Dates FDA Received: 12/03/2020; 02/25/2021
• Patient Sequence Number: 1