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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/03/2024
Event Type  malfunction  
Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
 
Event Description
The customer reported that the system is not producing an audible alarm.The device was in use on patient at time of event, there was no adverse event reported.
 
Manufacturer Narrative
A philips remote service engineer (rse) spoke with a customer onsite to evaluate the device in question.The rse indicated during an evaluation of the system that the system has no audible alarms due to the system speaker being unseated.The rse directed the customer to re-seat the device speaker to resolve their issue.The philips remote service engineer (rse) confirmed the customers device issue and resolve the device issue by reseating the system speaker.After the system speaker was re-seated the system was placed back into service.
 
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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
deborah currlin
3000 minuteman rd
andover, MA 01810
6172455900
MDR Report Key19213788
MDR Text Key341398616
Report Number1218950-2024-00306
Device Sequence Number1
Product Code MHX
UDI-Device Identifier00884838093041
UDI-Public00884838093041
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183387
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type 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
Is this an Adverse Event Report? No
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 04/03/2024
Initial Date FDA Received04/30/2024
Supplement Dates Manufacturer Received04/29/2024
Supplement Dates FDA Received05/28/2024
Was Device Evaluated by Manufacturer? Yes
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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