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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EARLYVUE VS30 VITALS MONITOR
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EARLYVUE VS30 VITALS MONITOR Back to Search Results
Model Number 863380
Device Problem Inappropriate Audible Prompt/Feedback (2280)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
Event Type  malfunction  
Event Description
The customer reported the problem of speaker failure.The device was not in clinical use at the time the reported issue was discovered.No adverse event involving a patient or user was reported by the customer.
 
Event Description
The customer reported the problem of speaker failure.The device was not in clinical use at the time the reported issue was discovered.No adverse event involving a patient or user was reported by the customer.
 
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Brand Name
EARLYVUE VS30 VITALS MONITOR
Type of Device
EARLYVUE VS30 VITALS MONITOR
MDR Report Key12296134
MDR Text Key265659261
Report Number9610816-2021-10276
Device Sequence Number1
Product Code DSJ
UDI-Device Identifier00884838091412
UDI-Public00884838091412
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
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2021
Distributor Facility Aware Date07/28/2021
Initial Date Manufacturer Received 07/28/2021
Initial Date FDA Received08/09/2021
Supplement Dates Manufacturer Received07/28/2021
Supplement Dates FDA Received11/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/25/2020
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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