MAUDE Adverse Event Report: BIO-RAD S1000 THERMAL CYCLER CHASSIS

Model Number S1000

Device Problems Device Emits Odor (1425); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2016

Event Type  malfunction  

Event Description

On (b)(6) 2016, blood center of wisconsin lab staff reports, instrument made a popping sound, burning smell then went dead.Unit serial number (b)(4).Unit returned to bio-rad for repair.

• Brand Name: S1000 THERMAL CYCLER CHASSIS
• Type of Device: THERMAL CYCLER
• Manufacturer (Section D): BIO-RAD; 255 linus pauling drive; hercules CA 94547
• MDR Report Key: 5802609
• MDR Text Key: 49957123
• Report Number: MW5063496
• Device Sequence Number: 1
• Product Code: OUL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: S1000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/10/2016
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1