MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH IH-INCUBATOR L

Model Number	009303
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported the ih-incubator l (first installed 2019) was overheating and started giving off a burning smell.Afterwards, the icons on the touch screen were no longer responsive.Nobody was harmed by this incident.A technical support representative advised the customer not to use the instrument.They were using an ortho incubator until a replacement unit arrived.The affected instrument was sent to the product support lab in parsippany nj for troubleshooting.There, the instrument was inspected and tested to see if the problem was replicable and to find the source of the problem.The power supply and fuse holder was inspected: no burns or manufacturing defects were found.The incubator powered on without issues.The touch screen is responsive and functional.The instrument was left on for a full working day and neither overheating nor a burning smell could be noticed.The instrument went into standby mode as intended and did not fail to power back on after touching the screen.Other than dust buildup on the blades and filter of the fan, no damage or defects have been found for the instrument's internal components.The instrument has been turned on, put in standby, and tested using its timer function to simulate regular use at a customer site.No overheating or burning has been observed and internal incubator temperature matches system reading.No damage or defects found in internal components of instrument.Overheating and burning smell reported by the customer was not reproduceable after using the instrument for several hours.

• Brand Name: IH-INCUBATOR L
• Common Device Name: IH-INCUBATOR L
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 16946832
• Report Number: 9610824-2023-00020
• Device Sequence Number: 20427126
• Product Code: KSZ
• UDI-Device Identifier: 07611969226344
• UDI-Public: (01)07611969226344
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: BK170066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 009303
• Device Catalogue Number: 009303
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown