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

Catalog Number	MU20503
Medical Device Problem Code	No Pressure (2994)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation has just started, results will be provided in a follow-up report.
Event or Problem Description
It was reported that the device was not able to build-up a sufficient airway pressure, the intended peep could not be kept as well.Further details are not known by now and thus, this report is filed in abundance of caution.
Event or Problem Description
It was reported that the device was not able to build-up a sufficient airway pressure, the intended peep could not be kept as well.Further details are not known by now and thus, this report is filed in abundance of caution.
Additional Manufacturer Narrative
A dräger field service engineer has tested the device in follow-up of the event.In combination with the dedicated patient circuit system were all readings for pressure/flow as well as for the peep within the specified tolerances.The device was returned to use and is in operation with no new issues reported since then.In an interview with the hospital, dräger could determine that the concerned device was used by a team of external doctors who were called-in for an emergency case.It is known that this external team typically operates another type of neonatal ventilator.Unfortunately, the repeated attempts of contacting the external team were unsuccessful and thus, no further details about the exact course of event could be obtained.In reflection of the aspect that the ventilator itself had no malfunction when having been tested in follow-up of the event and is still in use w/o issues, it is seen likely that the external team of users wasn't trained in the use of the dräger device and had maybe introduced accessories that they have brought with them, and which were not compatible with the dräger device.Dräger finally concludes that the reported observation was most likely related to lack of training and/or applicational aspects.H3 other text : see h10.

• Brand Name: RESUSCITAIRE RW82/WBR82
• Common Device Name: RESUSCITAIRE RADIANT WARMER
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 9783798000
• MDR Report Key: 18157906
• Report Number: 1220063-2023-00045
• Device Sequence Number: 7992507
• 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
• Serviced by Third Party (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): 04/26/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MU20503
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2010
• 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: Required Intervention
• Patient Sex: Unknown