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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS EARLYVUE; MULTI-PARAMETER PATIENT MONITOR

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PHILIPS MEDICAL SYSTEMS EARLYVUE; MULTI-PARAMETER PATIENT MONITOR Back to Search Results
Model Number 863380
Device Problem Inaudible or Unclear Audible Prompt/Feedback (2283)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
:the device was returned to philips for evaluation.Due to a change in decontamination processes which also involved a facility change, the device cannot be located.Due to age of the complaint, the case will be closed.If/when the device be located, evaluation of the device will be documented in the defoa database under defoa-2020-08-34124.The customer was sent a replacement device.Reference manufacturer's report number 1218950-2020-04913 previously submitted with incorrect registration number.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.The device was returned to philips but can not be located.
 
Event Description
The customer reported the problem of speaker malfunction.The device was not in use on a patient.
 
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Brand Name
EARLYVUE
Type of Device
MULTI-PARAMETER PATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
boeblingen 71034
GM  71034
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
hewlett-packard str.2
boeblingen 71034
GM   71034
MDR Report Key11019523
MDR Text Key222326507
Report Number9610816-2020-00456
Device Sequence Number1
Product Code DQA
UDI-Device Identifier00884838091412
UDI-Public(01)00884838091412
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190624
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/19/2020
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 Number863380
Device Catalogue Number863380
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/19/2020
Initial Date FDA Received12/16/2020
Was Device Evaluated by Manufacturer? No
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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