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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX
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PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX Back to Search Results
Model Number 866389
Device Problem No Audible Alarm (1019)
Patient Problem Ventricular Fibrillation (2130)
Event Date 07/04/2023
Event Type  Injury  
Event Description
The customer reported that central unit did not alarm when a patient went into vf arrest.
 
Manufacturer Narrative
Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
This final report is being submitted with reference to manufacturer's report 1218950-2023-00484 as this record has been identified as a duplicate and will be closed with no further investigation.
 
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Brand Name
PATIENT INFORMATION CENTER IX
Type of Device
PATIENT INFORMATION CENTER IX
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd
andover MA 01810
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd
andover MA 01810
Manufacturer Contact
hisham alzayat
3000 minuteman rd
andover, MA 01810
6172455900
MDR Report Key17463606
MDR Text Key320438365
Report Number1218950-2023-00529
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K153702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number866389
Device Catalogue Number866389
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/04/2023
Initial Date FDA Received08/04/2023
Supplement Dates Manufacturer Received07/04/2023
Supplement Dates FDA Received08/21/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/01/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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