10 LEAD ECG TRUNK AAMI/IEC 2M M1663A 989803144791

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 2020-01-27 for 10 LEAD ECG TRUNK AAMI/IEC 2M M1663A 989803144791 manufactured by Philips Medical Systems.

Event Text Entries

[181393827] Serial number unknown. A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[181393828] The customer reported a failure of the ecg trunk cable. Patient involvement is unknown. There was no reported patient incident/injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610816-2020-00035
MDR Report Key9633686
Report SourceUSER FACILITY
Date Received2020-01-27
Date of Report2020-01-23
Date Mfgr Received2020-01-23
Date Added to Maude2020-01-27
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 ContactMR. ROBERT CORNING
Manufacturer StreetHEWLETT-PACKARD STR.2
Manufacturer CityBOEBLINGEN 71034
Manufacturer CountryGM
Manufacturer Postal71034
Manufacturer G1PHILIPS MEDICAL SYSTEMS
Manufacturer Street3000 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal Code01810
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name10 LEAD ECG TRUNK AAMI/IEC 2M
Generic NameECG TRUNK CABLE
Product CodeDSA
Date Received2020-01-27
Model NumberM1663A
Catalog Number989803144791
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer AddressHEWLETT-PACKARD STR.2 BOEBLINGEN 71034 GM 71034


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-27

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