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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS EARLYVUE; EARLYVUE VS30 VITALS MONITOR
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PHILIPS MEDICAL SYSTEMS EARLYVUE; EARLYVUE VS30 VITALS MONITOR Back to Search Results
Model Number 863380
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Unable to confirm serial number.A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported that the device took a shock and the display is defective.The device was not in clinical use at the time the reported issue was discovered.
 
Manufacturer Narrative
H10: the device was received without the roll stand at philips bench repair for troubleshooting/evaluation.The bench repair technician (brt) tested the device and observed that the front panel assembly and lcd assembly were defective.The brt indicated that the parts were defective from the device falling.The brt replaced the front panel assembly and lcd assembly.Since the roll stand was not returned, it was not known if the mount on the roll stand was defective causing the device to fall.The device passed all functional tests and was returned to use.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
EARLYVUE
Type of Device
EARLYVUE VS30 VITALS MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
boeblingen 71034
GM  71034
MDR Report Key11362789
MDR Text Key234248312
Report Number9610816-2021-00056
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
PMA/PMN Number
K190624
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 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number863380
Device Catalogue Number863380
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2021
Was the Report Sent to FDA? No
Date Manufacturer Received02/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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