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	Low Oxygen Saturation (2477)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that draeger resuscitaire may not have been delivering adequate oxygen.There was a temporary desaturation reported but no further symptoms or consequences.
Additional Manufacturer Narrative
The investigation was started but is not yet concluded.We cannot exclude that the investigation alters the device or a sample of the batch concerned in a way which may affect any subsequent evaluation of the causes of the incident.We assume that such an analysis can begin 10 days following issuance of this initial report, unless the national competent authority contacts us within this time frame opposing an analysis which involves altering the device.H3 other text : ongoing.
Event or Problem Description
It was reported that draeger resuscitaire may not have been delivering adequate oxygen.There was a temporary desaturation reported but no further symptoms or consequences.
Additional Manufacturer Narrative
The user stated that the deviation between set and delivered fio2 values was related to the knob of the dosage valve which was moving freely on its axxis.Dräger has initiated repeated requests to obtain further information but those were not responded to.Hence, it is not possible to differentiate between the most likely scenarios of either knob becoming loose over time or due to a sudden event in form of impact of too high mechanical force.The entire device has a useful product life of 7 years - the unit involved in the particular incident was in use for more than 8 years already when the event occurred.The oxygen blender is subject to re-calibration in intervals of two years, a beginning loosening of the knob will most likely be detected.It is not known due to missing feedback when the last calibration cycle was performed.

• 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: 17742987
• Report Number: 1220063-2023-00031
• Device Sequence Number: 19892580
• Product Code: FMT
• UDI-Device Identifier: 04049098000215
• UDI-Public: 04049098000215
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2024

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 Catalogue Number: MU20503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown