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

Catalog Number	MU20503
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device turned-off by itself.Initially, the report did not contain any information that this may have occurred during patient use.Upon request for further information, dräger was made aware that a patient was involved and that the event led to a delay in patient treatment requiring resuscitation.No health consequences for patient have finally occurred.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : ongoing.
Additional Manufacturer Narrative
A complaint was received regarding a resuscitaire controller power switch not working.The customer stated there was a delay in patient treatment, due to the patient being moved; however, no negative outcome was confirmed.No further information was provided.A draeger technician went on site and verified the reported issue and replaced the power switch.No further issues have been reported.H3 other text : see h10.
Event or Problem Description
It was reported that the device turned-off by itself.Initially, the report did not contain any information that this may have occurred during patient use.Upon request for further information, dräger was made aware that a patient was involved and that the event led to a delay in patient treatment requiring resuscitation.No health consequences for patient have finally occurred.

• Brand Name: RESUSCITAIRE RW82/WBR82
• Common Device Name: RESUSCITAIRE RW82/WBR82
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA ; GM
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 9784470587
• MDR Report Key: 17832073
• Report Number: 1220063-2023-00032
• Device Sequence Number: 6759246
• Product Code: FMT
• UDI-Device Identifier: 04049098000215
• UDI-Public: (01)04049098000215(11)221021(93)MU20503-58
• 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): 05/01/2024

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: 09/20/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2022
• 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: Other; Life Threatening
• Patient Sex: Unknown