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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH EARLYVUE VS30 VITALS MONITOR
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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH EARLYVUE VS30 VITALS MONITOR Back to Search Results
Model Number EARLYVUE VS30 VITALS MONITOR
Device Problem No Audible Prompt/Feedback (2282)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/05/2021
Event Type  malfunction  
Event Description
The customer reported that the device displayed a speaker malfunction, performed audio test but it did not cleared the error and would like a speaker replacement.It is unknown if the device was in use at time of event, no adverse event was reported.
 
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Brand Name
EARLYVUE VS30 VITALS MONITOR
Type of Device
EARLYVUE VS30 VITALS MONITOR
Manufacturer (Section D)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM  71034
Manufacturer (Section G)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM   71034
Manufacturer Contact
tara mackinnon
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM   71034
7031463203
MDR Report Key12915246
MDR Text Key281602415
Report Number9610816-2021-10520
Device Sequence Number1
Product Code DSJ
UDI-Device Identifier00884838091412
UDI-Public00884838091412
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 Facility
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEARLYVUE VS30 VITALS MONITOR
Device Catalogue Number863380
Date Manufacturer Received11/05/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/14/2020
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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