MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC ISOLETTE 8000; INFANT INCUBATOR WITH OXYGEN, SCALE AND HUMIDITY

Model Number	MU20600
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that due to the unstable body temperature of the premature baby, the incubator was used to ensure the stability of the baby's body temperature.When using the incubator, the humidifier did not heat up, tripped and cut off the power, which could not provide a constant temperature and humidity environment for the baby, resulting in hypothermia and tunneling immediately replace with another incubator for warmth.Additional information was provided clarifying that the device failed to turn on as intended when the baby was lying in the incubator.The baby was immediately put into another incubator.No other medical intervention or measures were taken.It was also stated that the site does not usually perform the required operational checkout procedure prior to use.Additionally, the incubator was not prewarmed prior to placing the baby in the unit.The site uses sterile water in the device for the humidity.As the site is using sterile water instead of the recommended distilled water for the humidity, this results in earlier failures of the humidity system.
Additional Manufacturer Narrative
The site suspected a short circuit of the humidifier was the cause of the failure to power up (which can result from the corrosion from the sterile water being used).A draeger technician provided a quote.To date the customer has not accepted the quote.Root cause was identified as user error where the user is not performing the required operational checkout procedure or the required prewarm of the device and not using distilled water for the humidifier.The isolette 8000 incubator instructions for use provides the following.Warning - risk of death or serious injury.Do not use the incubator if it fails to function as described in the operational checkout procedure.Warning - risk of death or serious injury.Before placing the infant in the incubator, prewarm the incubator to the temperature prescribed by the attending physician, or according to nursing protocol.Caution - risk of injury or equipment damage.Use distilled water only (<10 ppm total dissolved solids).Sterile water is not an acceptable substitute for distilled water.The maintenance schedule includes replacement of the humidity reservoir assembly every 2 years.

• Brand Name: ISOLETTE 8000
• Common Device Name: INFANT INCUBATOR WITH OXYGEN, SCALE AND HUMIDITY
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA
• MDR Report Key: 17221465
• Report Number: 2510954-2023-00008
• Device Sequence Number: 6224134
• Product Code: FMZ
• UDI-Device Identifier: 04049098000178
• UDI-Public: (01)04049098000178(11)170222(17)190221(93)MU20600-30
• Combination Product (Y/N): N
• PMA/510(K) Number: K001242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MU20600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2017
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 1 DA
• Patient Sex: Female