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U.S. Department of Health and Human Services

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

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COVIDIEN 31.1914.21 H914SG ECG ELDIAGF448X34MMX30; ELECTRODE, ELECTROCARDIOGRAPH Back to Search Results
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.
 
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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 Key10659025
MDR Text Key213074865
Report Number9710060-2020-00203
Device Sequence Number1
Product Code DRX
Combination Product (y/n)N
Number of Events Reported1
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 Number31.1914.21
Device Catalogue Number31.1914.21
Device Lot Number20182C
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/29/2020
Initial Date FDA Received10/09/2020
Supplement Dates Manufacturer Received09/29/2020
09/29/2020
Supplement Dates FDA Received12/03/2020
02/25/2021
Patient Sequence Number1
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