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

Model Number	009303
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2019
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 that the ih-incubator would give a burning smell and would not power up.One of our field service engineers was on site to check on the instrument.The customer told him that they had poured saline over the device into another container, missed and dumpled at least a 1/2 gallon of saline on top of the device.This caused a burning smell and damaged the device.The customer powered down the ih-incubator right after this occurred and let it sit.Our field service engineer did not see any physical damage to the outside of the device.When trying to power up the device, it would not power up.The field service engineer asked the customer if any bodily harm occured, but there was none.No erroneous sample results occurred.The devices was not being used at the time this incident occurred.The main board and the power supply was checked.The ih-incubator was damaged because of a handling failure by the customer.The user manual contains a clear safety note, saying: "! danger, contact with water: the ih-incubator l is not protected against water penetration.Water penetrating the instrument may cause an electrical discharge.Do not install the ih-incubator l near water or in any place where a risk of water penetration is possible".

• 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
• MDR Report Key: 8829953
• Report Number: 9610824-2019-00038
• Device Sequence Number: 242870
• Product Code: KSZ
• UDI-Device Identifier: 07611969226344
• UDI-Public: (01)07611969226344
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: BK170066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2019

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1