MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS INC RESUSCITAIRE RW82/WBR82; RESUSCITAIRE RADIANT WARMER

Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Hypothermia (1915)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As the customer reported the infant¿s skin temperature was reading higher than what was set on the resuscitaire.Reporting based on evaluation of recurrence potential for harm.No adverse impact reported.
Additional Manufacturer Narrative
Dräger reached out to the contact person in the hospital but was not able to obtain additional information in regard to the use conditions under which the issue was observed.The device is not under a service contract; reportedly it has been checked by an in-house biomedical engineer and did not exhibit any malfunction during these tests.A case-specific evaluation is not possible on the base of the available information.Based on experience, the reported issue is rather related to application aspects than to technical deviations; the expertise of the biomed substantiates that.If the device is in skin temperature mode, a respective probe has to be used for measurement.For an exact measurement, the skin probe has to be positioned in direct line with the heat flow from the warmer module, a specific kind of probe with reflective cover has to be used; the ifu refers in detail to the correct use.Disregarding details may affect the skin temperature measurement and cause measurement errors and/or unexpected therapeutic results.The concerned device was never removed from use with no further problems reported to date.Dräger will discuss with the hospital the potential necessity to send an application specialist to the facility for the purpose of identifying potential training needs of the users.

• Brand Name: RESUSCITAIRE RW82/WBR82
• Common Device Name: RESUSCITAIRE RADIANT WARMER
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS INC; 6 tech drive; andover MA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS INC; 6 tech drive; andover MA
• Manufacturer Contact: 6 tech drive; andover, MA ; 9784470587
• MDR Report Key: 17911695
• Report Number: 1220063-2023-00036
• Device Sequence Number: 7497390
• Product Code: FMT
• UDI-Device Identifier: 04049098000215
• UDI-Public: (01)04049098000215(11)210330(93)MU20503-56
• Combination Product (Y/N): N
• PMA/510(K) Number: K120642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2023

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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
• Patient Sex: Unknown