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

Catalog Number	MU20503
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A dräger service engineer has checked all devices in the care unit during an on-site visit and found no accuracy issues with them, all scales were properly calibrated.The engineer has then asked for a demonstration by the staff how an infant weighing procedure is usually done.During this demonstration, some use aspects were identified to have potential to influence the accuracy of the weighing result or to cause fluctuating readings.The engineer gave some recommendations on proper positioning of blanket and mattress cover and how to avoid straining.Dräger finally concludes that there is no issue with the product(s) which would require repair or correction and that the reported observation was related to unfavorable handling conditions.
Event or Problem Description
It was reported that an inaccuracy of the weighing results was observed with the device's scale.As per report, this did not lead to direct or indirect consequences for the patient.

• 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: 17668656
• Report Number: 9611500-2023-00310
• Device Sequence Number: 7105658
• Product Code: FMT
• UDI-Device Identifier: 04049098000215
• UDI-Public: (01)04049098000215(11)230630(17)250630(93)MU20503-58
• 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): 09/01/2023

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 Catalogue Number: MU20503
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 09/01/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown