HEARTSTART 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 2014-10-15 for HEARTSTART XL M4735A manufactured by Philips Medical Systems.

Event Text Entries

[4964533] The customer reported, the machine cannot "boot up". There was no report of pt involvement.
Patient Sequence No: 1, Text Type: D, B5


[12388394] (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 Number1218950-2014-06184
MDR Report Key4196918
Report Source01,06
Date Received2014-10-15
Date of Report2014-09-23
Date Mfgr Received2014-09-23
Device Manufacturer Date2009-07-01
Date Added to Maude2014-10-24
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 ContactROBERT CORNING
Manufacturer Street3000 MINUTEMAN RD.
Manufacturer CityANDOVER MA 018101099
Manufacturer CountryUS
Manufacturer Postal018101099
Manufacturer Phone9786593679
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEARTSTART XL
Product CodeMJK
Date Received2014-10-15
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 01810109 US 01810 1099


Patients

Patient NumberTreatmentOutcomeDate
10 2014-10-15

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