3M RED DOT ECG ELECTRODE 2670-5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for 3M RED DOT ECG ELECTRODE 2670-5 manufactured by 3m Health Care.

Event Text Entries

[133829018] Snap separates from the ecg electrode. This has occurred numerous times. This has significant implications to patient care. This is event #2 of 2 with the same lot number on the same emergency incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5083211
MDR Report Key8260658
Date Received2019-01-17
Date of Report2019-01-03
Date of Event2018-11-10
Date Added to Maude2019-01-18
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand Name3M RED DOT ECG ELECTRODE
Generic NameECG ELECTRODE
Product CodeDRX
Date Received2019-01-17
Model Number2670-5
Catalog Number2670-5
Lot Number202006FH
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
Manufacturer3M HEALTH CARE
Manufacturer AddressST. PAUL MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-17

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