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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 Problems Disconnection (1171); Loose or Intermittent Connection (1371); Intermittent Communication Failure (4038)
Patient Problems Hypoxia (1918); Insufficient Information (4580)
Event Date 12/08/2022
Event Type  Injury  
Event Description
The customer reported that on december 8th there was no transmission of the vital parameters from the patient monitor to the piic ix control center in the ward base between 2:53 p.M.And 6:26 p.M.The child was found in time by the nursing staff and successfully resuscitated and transferred to the children's intensive care unit.
 
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.(b)(6).
 
Manufacturer Narrative
The issue has been reviewed and the reported problem turned out to be not reportable.
 
Event Description
The customer reported that on december 8th there was no transmission of the vital parameters from the patient monitor to the piic ix control center in the ward base between 2:53 p.M.And 6:26 p.M.The child was found in time by the nursing staff and successfully resuscitated and transferred to the children's intensive care unit.The device has been checked with preventive maintenance tasks and safety tests and has been confirmed that the product is functioning as intended and operating per specifications and no failure was identified.Based on the information available and the testing conducted, the cause of the reported problem was a defective network cable.The monitor connected directly to the control panel when the replaced network patch cable was plugged in and data transmission was re-established.The defective network cable was a third party product and therefor this issue is determined to be a non product malfunction of the pic ix.
 
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that on december 8th there was no transmission of the vital parameters from the patient monitor to the piic ix control center in the ward base between 2:53 p.M.And 6:26 p.M.The child was found in time by the nursing staff and successfully resuscitated and transferred to the children's intensive care unit.Based on the information available and the testing conducted, the cause of the reported problem was a loose network cable.According to the information provided, the monitor connected directly to the control panel when the network cable was re-plugged in and data transmission was re-established.
 
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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 Key16002486
MDR Text Key305679686
Report Number1218950-2022-01063
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K153702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,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 Operator Health Professional
Device Model Number866389
Device Catalogue Number866389
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/08/2022
Initial Date FDA Received12/19/2022
Supplement Dates Manufacturer Received01/16/2023
02/14/2023
Supplement Dates FDA Received02/14/2023
02/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2018
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) Life Threatening;
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