MEDI-TRACE# CADENCE ADULT RTS ZOLL 22770R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-03-27 for MEDI-TRACE# CADENCE ADULT RTS ZOLL 22770R manufactured by Covidien.

Event Text Entries

[187558462] 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


[187558523] The customer reported that the defibrillation patches were applied anterior/posterior to chest and back and connected to a defibrillator, after the initial shock of 150 joules and unsuccessful cardioversion the staff noticed a faint burning smell and heard a pop. The pad placement and adherence were checked and agree to be correctly placed and adhered. The second shock was delivered at 200 joules, cardioversion was successful with similar result of burning smell. After the pads were removed the patient was found to have small burn marks on mid-chest but none on the back. The prominent burn mark was approximately 4 cm long with several smaller marks scattered where the edge of the pad had been. Silvadine was applied to the area per physician's order.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219103-2020-00278
MDR Report Key9891812
Report SourceHEALTH PROFESSIONAL,OTHER,USE
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-02-13
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-27
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 Phone5086172514
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 Details

Brand NameMEDI-TRACE# CADENCE ADULT RTS ZOLL
Generic NamePACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
Product CodeDRO
Date Received2020-03-27
Model Number22770R
Catalog Number22770R
Lot Number934328X
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 2020-03-27

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