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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PHILIPS INTELLIVUE MP5 PATIENT MONITOR

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PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PHILIPS INTELLIVUE MP5 PATIENT MONITOR Back to Search Results
Catalog Number RQPH2105- NSET
Device Problems Circuit Failure (1089); Battery Problem (2885)
Patient Problem No Patient Involvement (2645)
Event Date 07/25/2019
Event Type  malfunction  
Manufacturer Narrative
The complaint device was returned for evaluation.Visual inspection was performed and identified that the mp5 tag was missing.Technical evaluation was performed which confirmed the reported issue of there being no power on the recorder.The technician replaced the recorder board with a refurbished one, checked for case damage, inspected the circuit board, checked that the options were set to h10 a04 c00 c01 c15 c20, set the soft to m.04.00, and tested the device on a simulator.The display test, ecg test, network lan/wlan check, nibp test, on/off power test, recorder test, temperature test, and final visual inspection all passed.Based on the reported event and the device evaluation analysis the root cause was determined to be a recorder board failure due to aged parts.No further investigation is required.This type of event will continue to be monitored.
 
Event Description
Reportedly, post purchase, there was no power to the recorder.There was no report of patient involvement.
 
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Brand Name
PHILIPS INTELLIVUE MP5 PATIENT MONITOR
Type of Device
MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
hewlett-packard-str. 2
D-710 34
GM  D-71034
Manufacturer (Section G)
AVANTE HEALTH SOLUTIONS
212 avenida fabricante
san clemente CA 92672
Manufacturer Contact
jenna vargas
212 avenida fabricante
san clemente, CA 92672
8004495328
MDR Report Key8908274
MDR Text Key167647786
Report Number3007409280-2019-00005
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082633
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/29/2019
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 Catalogue NumberRQPH2105- NSET
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/29/2019
Initial Date FDA Received08/19/2019
Was Device Evaluated by Manufacturer? Yes
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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