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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MULTI MEASUREMENT SERVER X2; PATIENT MONITOR
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PHILIPS MEDICAL SYSTEMS INTELLIVUE MULTI MEASUREMENT SERVER X2; PATIENT MONITOR Back to Search Results
Model Number M3002A
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported a drop of the x2 device due to a faulty extension holder.The device was not reported to be in use on a patient.
 
Manufacturer Narrative
H10: the customer stated that drop of the x2 device due to a faulty extension holder.The remote support sent a field service engineer (fse)to investigate the problem onsite.The device was evaluated during an onsite operation.The fse stated that the attaching area of the top cover of the device broke off and the device then dropped.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
INTELLIVUE MULTI MEASUREMENT SERVER X2
Type of Device
PATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
boeblingen 71034
GM  71034
MDR Report Key11398911
MDR Text Key239104395
Report Number9610816-2021-00059
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
PMA/PMN Number
K071426
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 02/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3002A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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