MEDISYSTEMS K3-9642/9795

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-06 for MEDISYSTEMS K3-9642/9795 manufactured by Medisystems.

Event Text Entries

[360071] An internal trandsucer protector on a fresenius 2008e machine was found to have a small amount of blood in it. Reporter immediately changed the internal transducer protector. There is no way to determine how long the problem existed or the lot number of the external transducer protectors used.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW1032560
MDR Report Key540713
Date Received2004-07-06
Date of Report2004-07-06
Date Added to Maude2004-08-27
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 FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameMEDISYSTEMS
Generic NameTRANSDUCER PROTECTOR
Product CodeFIB
Date Received2004-07-06
Model NumberK3-9642/9795
Catalog NumberK3-9642/9795
Lot NumberUNABLE TO DETERMINE
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key530024
ManufacturerMEDISYSTEMS
Manufacturer Address701 PIKE ST 16TH FLOOR SEATTLE WA 98101 US

Device Sequence Number: 2

Brand Name*
Generic Name*
Product CodeFII
Date Received2004-07-06
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key530025
Manufacturer*
Manufacturer Address* * US

Patients

Patient NumberTreatmentOutcomeDate
10 2004-07-06
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