MAUDE Adverse Event Report: COVIDIEN 31.1925.21 H92SG ECGELPRSTFOAM57X34MMX50; ELECTRODE, ELECTROCARDIOGRAPH

Model Number 31.1925.21

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reports that they encountered problems with the voltage.They keep low voltage but not high voltage.No patient injury.Additional information received on (b)(6) 2020 states that the trace reading could only be seen with the low voltage which caused inaccurate readings.

• Brand Name: 31.1925.21 H92SG ECGELPRSTFOAM57X34MMX50
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN; quedlinburger strasse 39a; halberstadt D3882 0; GM D38820
• Manufacturer (Section G): COVIDIEN; quedlinburger strasse 39a; halberstadt D3882 0; GM D38820
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10471026
• MDR Text Key: 206964410
• Report Number: 9710060-2020-00201
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 31.1925.21
• Device Catalogue Number: 31.1925.21
• Device Lot Number: 20151C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1