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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP70
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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP70 Back to Search Results
Model Number 862451
Device Problem Delayed Alarm (1011)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2023
Event Type  malfunction  
Event Description
It was reported that when the patient o2 saturation goes below what they have set, it takes several minutes to alarm.The 92-100 is the alarm range.90-91 is yellow.<90 red alarm.Customer reported it takes many minutes for the spo2 alarm to trigger yellow.The device was in use at time of event, there was no adverse event reported.
 
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Manufacturer Narrative
A remote service engineer (rse) spoke to the customer and confirmed that the configuration had the low alarm delay set at 10 seconds, and the desaturation delay set at 20 seconds, so the rse explained that it could possibly be 30 seconds before a desaturation alarm occurs.It was confirmed that spo2 was a solid pleth waveform with no artifact.A good faith effort (gfe) was performed to clarify the issue, and it was indicated that the patient's spo2 values were varying widely, causing the algorithm's delay condition to not be met, though the customer expected an alarm immediately.It was also indicated the patient's spo2 values were above the alarm limit a majority of the time.The customer declined onsite dispatch.Based on the information available, the reported issue was caused by user error / user missunderstanding.
 
Event Description
It was reported that when the patient o2 saturation goes below what they have set, it takes several minutes to alarm.The 92-100 is the alarm range.90-91 is yellow.<90 red alarm.Customer reported it takes many minutes for the spo2 alarm to trigger yellow.The device was in use at time of event, there was no adverse event reported.
 
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Brand Name
INTELLIVUE MP70
Type of Device
INTELLIVUE MP70
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
hauke schik
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM   71034
7031463203
MDR Report Key18418487
MDR Text Key331665933
Report Number9610816-2023-00693
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151681
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number862451
Device Catalogue Number862451
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/25/2008
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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