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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PIC IX HARDWARE
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PHILIPS NORTH AMERICA LLC PIC IX HARDWARE Back to Search Results
Model Number 866424
Device Problem Wireless Communication Problem (3283)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/30/2022
Event Type  malfunction  
Event Description
The customer reported that that central monitoring was offline for the entire hospital building.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
 
Manufacturer Narrative
Reporter institution phone number: (b)(6).Reporter phone number : (b)(6).A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer reported that that central monitoring was offline for the entire hospital building.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
 
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Brand Name
PIC IX HARDWARE
Type of Device
PIC IX HARDWARE
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer Contact
jeanne ahearn
222 jacobs st
cambridge, MA 02141
6172455900
MDR Report Key14626378
MDR Text Key293538503
Report Number1218950-2022-00471
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K102495
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number866424
Device Catalogue Number866424
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/02/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/07/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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