HEART START XL M4735A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2015-01-15 for HEART START XL M4735A manufactured by Philips Medical Systems.

Event Text Entries

[14881872] The customer reported that the heartstart xl had a faulty pca control card. There was no report of pt involvement.
Patient Sequence No: 1, Text Type: D, B5


[15288243] (b)(4). A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1218950-2015-00280
MDR Report Key4438702
Report Source01,06
Date Received2015-01-15
Date of Report2014-12-24
Date Mfgr Received2014-12-24
Device Manufacturer Date2006-02-01
Date Added to Maude2015-02-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactBETTERY HARRIS
Manufacturer Street3000 MINUTEMAN RD.
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal01810
Manufacturer Phone9786593311
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEART START XL
Generic NameDEFIBRILLATOR
Product CodeMJK
Date Received2015-01-15
Model NumberM4735A
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer Address3000 MINUTEMAN RD. ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
10 2015-01-15

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