3010188-020 QC RTS 1/P 10/B 50 PM20003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-12-17 for 3010188-020 QC RTS 1/P 10/B 50 PM20003 manufactured by Covidien.

Event Text Entries

[130560819] 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


[130560820] The customer reports: hydrogel delamination was found on one set of electrode.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219103-2018-00218
MDR Report Key8171299
Report SourceUSER FACILITY
Date Received2018-12-17
Date of Report2019-02-26
Date of Event2018-12-12
Date Mfgr Received2018-12-13
Date Added to Maude2018-12-17
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 Name3010188-020 QC RTS 1/P 10/B 50
Generic NamePACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
Product CodeMLN
Date Received2018-12-17
Model NumberPM20003
Catalog NumberPM20003
Lot Number632213
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No0
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address2 LUDLOW PARKWAY CHICOPEE MA 01022 US 01022

Device Sequence Number: 1

Brand Name3010188-020 QC RTS 1/P 10/B 50
Generic NamePACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
Product CodeDRO
Date Received2018-12-17
Model NumberPM20003
Catalog NumberPM20003
Lot Number632213
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address2 LUDLOW PARKWAY CHICOPEE MA 01022 US 01022


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-17

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