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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS BILICHEK; BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
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PHILIPS MEDICAL SYSTEMS BILICHEK; BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM Back to Search Results
Model Number BILICHEK
Device Problem Output Problem (3005)
Patient Problem Test Result (2695)
Event Date 11/02/2019
Event Type  malfunction  
Event Description
Transcutaneous bilirubin check were done on 4 nicu patients that results were high requiring multiple phototherapy treatments.Because we ran out of lights, neo ordered serum bilirubin to confirm the transcutaneous results.Noted that transcutaneous measurements were far off from the serum total bili.These are the following patients affected: transcutaneous bilirubin (tcb) - 10.8, serum 1.9.Transcutaneous bilirubin (tcb) - 15.6, serum 8.9.Transcutaneous bilirubin (tcb) - 18.2, serum 10.8.Transcutaneous bilirubin (tcb) - 16.1, no serum drawn but started on double phototherapy.
 
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Brand Name
BILICHEK
Type of Device
BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
2039 concourse dr
saint louis MO 63146
MDR Report Key9327529
MDR Text Key166539729
Report Number9327529
Device Sequence Number1
Product Code MQM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/05/2019
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 Model NumberBILICHEK
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/05/2019
Device Age8 YR
Event Location Hospital
Date Report to Manufacturer11/15/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age3 DA
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