S1000 AND C1000 (TOUCH) THERMAL CYCLER CHASSIS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-18 for S1000 AND C1000 (TOUCH) THERMAL CYCLER CHASSIS manufactured by Bio-rad.

Event Text Entries

[49958963] On (b)(6) 2016 bio-rad service engineer, (b)(6) visited (b)(6) to replace power supplies on unit serial numbers: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5063494
MDR Report Key5802607
Date Received2016-07-18
Date of Report2016-07-12
Date of Event2016-06-24
Date Added to Maude2016-07-19
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 Sequence Number: 1

Brand NameS1000 AND C1000 (TOUCH) THERMAL CYCLER CHASSIS
Generic NameTHERMAL CYCLER
Product CodeOUL
Date Received2016-07-18
Returned To Mfg2016-06-24
Model NumberS1000 AND C1000
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBIO-RAD
Manufacturer Address255 LINUS PAULING DRIVE HERCULES CA 94547 US 94547

Device Sequence Number: 2

Brand NameS1000 AND C1000 (TOUCH) THERMAL CYCLER CHASSIS
Generic NameTHERMAL CYCLER
Product CodeOUL
Date Received2016-07-18
Model NumberS1000 AND C1000
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No2
Device Event Key0
ManufacturerBIO-RAD
Manufacturer Address255 LINUS PAULING DRIVE HERCULES CA 94547 US 94547

Device Sequence Number: 3

Brand NameS1000 AND C1000 (TOUCH) THERMAL CYCLER CHASSIS
Generic NameTHERMAL CYCLER
Product CodeOUL
Date Received2016-07-18
Model NumberS1000 AND C1000
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No3
Device Event Key0
ManufacturerBIO-RAD
Manufacturer Address255 LINUS PAULING DRIVE HERCULES CA 94547 US 94547

Device Sequence Number: 4

Brand NameS1000 AND C1000 (TOUCH) THERMAL CYCLER CHASSIS
Generic NameTHERMAL CYCLER
Product CodeOUL
Date Received2016-07-18
Model NumberS1000 AND C1000
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No4
Device Event Key0
ManufacturerBIO-RAD
Manufacturer Address255 LINUS PAULING DRIVE HERCULES CA 94547 US 94547


Patients

Patient NumberTreatmentOutcomeDate
10 2016-07-18

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