KENDALL DL 33541

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-02 for KENDALL DL 33541 manufactured by Unk.

Event Text Entries

[59406161] Connectivity issue with kendall dl mx40 5 lead adapter non spo2 causing lead error alerts.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5065843
MDR Report Key6080978
Date Received2016-11-02
Date of Report2016-11-02
Date Added to Maude2016-11-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameKENDALL DL
Generic NameMX40 5 LEAD ADAPTER NON SPO2
Product CodeDRW
Date Received2016-11-02
Returned To Mfg2016-11-02
Catalog Number33541
Lot Number274146
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
10 2016-11-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.