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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 Device Fell (4014)
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 that the device has fallen.The device was in use on a patient.There was no report of patient or user harm.
 
Manufacturer Narrative
H10: it was unknown on how the device fell as there was no additional information whether the device was on a wall mount or a roll stand.A repair quotation has been provided to the customer.However, as of the date of closure of this complaint, the customer has not accepted the quotation.If the customer approves the quote, the complaint will be reopened and updated.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
3000 minuteman road
andover MA 01810
MDR Report Key11308524
MDR Text Key232514975
Report Number1218950-2021-00855
Device Sequence Number1
Product Code DQA
UDI-Device Identifier00884838075900
UDI-Public(01)00884838075900
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 02/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number863380
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2021
Was the Report Sent to FDA? No
Date Manufacturer Received02/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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