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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH EARLYVUE VS30 VITAL SIGNS MONITOR; ALARM, BLOOD-PRESSURE
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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH EARLYVUE VS30 VITAL SIGNS MONITOR; ALARM, BLOOD-PRESSURE Back to Search Results
Model Number 863380
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Date 11/23/2021
Event Type  malfunction  
Event Description
Biomedical engineering escalated their investigation due to an increase in related service requests from nursing unit a.The event: biomed team fielded several calls of spo2 not working/dropping out when using philips vs30 early vue monitors in "continuous sp02 monitoring mode." (nursing unit a's customer population is mostly covid positive customers who need continuous spo2 monitoring.) problem: frequent drop out or spo2 stops function, action taken: cable and/or sensor replaced, result: monitor starts working again.Philips clinical support was contacted by biomed team and they stated that the nellcor adult reusable finger sensor, part #ds-100a, "is not validated by philips for use with the early vue vital signs monitor." however, the philip sales representative insinuated that "ds-100a will work with the vital signs monitor." philips has not confirmed compatibility and there is nothing in writing indicating compatibility, but philips sells the early vue vital signs monitors indicating that the nellcor sensors will work.Philips is aware of the drop out issue according to their clinical support, but they do not have a resolution for this issue at this time.The biomed team has been in contact with the local philips vital signs account manager who informed biomed that philips is working on validation of the nellcor sensors for use, but philips has not yet completed this validation.This facility has an open case with philips clinical support.Manufacturer response for vital signs monitor, early vue vital signs monitor (per site reporter): we have been in contact with local philips vital signs account manager.He informs us that philips is working on validation of the nellcor sensors for use but have not yet completed that validation.
 
Event Description
Biomedical engineering escalated their investigation due to an increase in related service requests from nursing unit a.The event: biomed team fielded several calls of spo2 not working/dropping out when using philips vs30 early vue monitors in "continuous sp02 monitoring mode." (nursing unit a's customer population is mostly covid positive customers who need continuous spo2 monitoring.) problem: frequent drop out or spo2 stops function, action taken: cable and/or sensor replaced, result: monitor starts working again.Philips clinical support was contacted by biomed team and they stated that the nellcor adult reusable finger sensor, part #ds-100a, "is not validated by philips for use with the early vue vital signs monitor." however, the philip sales representative insinuated that "ds-100a will work with the vital signs monitor." philips has not confirmed compatibility and there is nothing in writing indicating compatibility, but philips sells the early vue vital signs monitors indicating that the nellcor sensors will work.Philips is aware of the drop out issue according to their clinical support, but they do not have a resolution for this issue at this time.The biomed team has been in contact with the local philips vital signs account manager who informed biomed that philips is working on validation of the nellcor sensors for use, but philips has not yet completed this validation.This facility has an open case with philips clinical support.Manufacturer response for vital signs monitor, early vue vital signs monitor (per site reporter): we have been in contact with local philips vital signs account manager.He informs us that philips is working on validation of the nellcor sensors for use but have not yet completed that validation.
 
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Brand Name
EARLYVUE VS30 VITAL SIGNS MONITOR
Type of Device
ALARM, BLOOD-PRESSURE
Manufacturer (Section D)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
3000 minuteman road
mail stop 4202
andover MA 01810
MDR Report Key12967384
MDR Text Key282001012
Report Number12967384
Device Sequence Number1
Product Code DSJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/07/2021,12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number863380
Device Catalogue Number863380
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/07/2021
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer12/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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