CADENCE PHYSIO QC ADULT RTS 22550R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-02-18 for CADENCE PHYSIO QC ADULT RTS 22550R manufactured by Covidien.

Event Text Entries

[136608600] 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.
Patient Sequence No: 1, Text Type: N, H10


[136608601] The customer reported the defib pads arced and the gel melted off while being used. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219103-2019-00224
MDR Report Key8347116
Report SourceOTHER
Date Received2019-02-18
Date of Report2019-10-23
Date of Event2018-12-20
Date Mfgr Received2019-02-11
Date Added to Maude2019-02-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJILL SARAIVA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524970
Manufacturer G1COVIDIEN
Manufacturer Street2 LUDLOW PARKWAY
Manufacturer CityCHICOPEE MA 01022
Manufacturer CountryUS
Manufacturer Postal Code01022
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameCADENCE PHYSIO QC ADULT RTS
Generic NamePACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
Product CodeMLN
Date Received2019-02-18
Model Number22550R
Catalog Number22550R
Lot Number824256X
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No0
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address2 LUDLOW PARKWAY CHICOPEE MA 01022 US 01022

Device Sequence Number: 1

Brand NameCADENCE PHYSIO QC ADULT RTS
Generic NamePACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
Product CodeDRO
Date Received2019-02-18
Model Number22550R
Catalog Number22550R
Lot Number824256X
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address2 LUDLOW PARKWAY CHICOPEE MA 01022 US 01022


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-18

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