INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 866148

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-08-31 for INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 866148 manufactured by Philips Medical Systems.

Event Text Entries

[118901923] A follow up report will be submitted once the investigation is complete. Patient information has been requested. Serial number is unknown at time of report.
Patient Sequence No: 1, Text Type: N, H10


[118901924] The customer has alleged a drug "overdose" event occurred due to a user drug order configuration that resulted in a overdose of paracetamol iv where a 3. 5 kg patient was prescribed 45 mg of paracetamol iv and the max should be 10 mg/kg iv for this patient. The drug was given. While it was described that the patient was not harmed, based on the patient being an infant and the inappropriate dosing, conservatively philips will classify this event as a serious injury based upon the limited initial information provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1218950-2018-07055
MDR Report Key7837275
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-08-31
Date of Report2018-08-29
Date of Event2018-08-28
Date Mfgr Received2018-08-29
Date Added to Maude2018-08-31
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 ContactMS. BETTY HARRIS
Manufacturer Street3000 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal01810
Manufacturer Phone9786871501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0
Generic NameCLINICAL INFORMATION MANAGEMENT SYSTEM
Product CodeDXJ
Date Received2018-08-31
Model Number866148
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer Address3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-08-31

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