ELECTRODE ADULT 4.5X6.25 DEFIBRILATION 22550A

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 2018-08-21 for ELECTRODE ADULT 4.5X6.25 DEFIBRILATION 22550A manufactured by Covidien.

Event Text Entries

[117831195] Submit date: 8/21/2018. 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


[117831196] Customer reports: the covidien defib pads are not connecting while in patient use.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219103-2018-00200
MDR Report Key7803015
Report SourceUSER FACILITY
Date Received2018-08-21
Date of Report2018-12-03
Date of Event2018-07-31
Date Mfgr Received2018-07-31
Date Added to Maude2018-08-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactEDWARD ALMEIDA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524151
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 NameELECTRODE ADULT 4.5X6.25 DEFIBRILATION
Generic NamePACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
Product CodeMLN
Date Received2018-08-21
Model Number22550A
Catalog Number22550A
Lot Number817308X
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No0
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address2 LUDLOW PARKWAY CHICOPEE MA 01022 US 01022

Device Sequence Number: 1

Brand NameELECTRODE ADULT 4.5X6.25 DEFIBRILATION
Generic NamePACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
Product CodeDRO
Date Received2018-08-21
Model Number22550A
Catalog Number22550A
Lot Number817308X
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address2 LUDLOW PARKWAY CHICOPEE MA 01022 US 01022


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-21

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