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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KENDALL DL; MX40 5 LEAD ADAPTER NON SPO2
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KENDALL DL; MX40 5 LEAD ADAPTER NON SPO2 Back to Search Results
Catalog Number 33541
Device Problems Device Displays Incorrect Message (2591); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Connectivity issue with kendall dl mx40 5 lead adapter non spo2 causing lead error alerts.
 
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Brand Name
KENDALL DL
Type of Device
MX40 5 LEAD ADAPTER NON SPO2
MDR Report Key6080978
MDR Text Key59406161
Report NumberMW5065843
Device Sequence Number1
Product Code DRW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number33541
Device Lot Number274146
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2016
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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