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

Catalog Number	MU20503
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
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 users observed electrical sparking inside the device.It was confirmed that this did not lead to an injury for the patient.
Additional Manufacturer Narrative
A complaint was received regarding the draeger resuscitaire where the customer states that the overhead heater sparked above the patient.There was no adverse patient impact or injury reported.It was confirmed that some of the sparks landed on the bassinet and not on the patient.It is unknown which part of the overhead heater sparked.A draeger technician went onsite and evaluated the device.The technician found that the heater element pulses more than expected when turned on.The front end of the heater element appeared to be burnt on the cable connection to the main element.It was also observed that the front end has a more prominent black spot on the element.As a precautionary measure, the draeger technician replaced the heater.The heater was returned for investigation and evaluated by this investigator.The heater was received in good physical condition with no discoloration from heat stress.The heater had a date code of 0122 indicating the heater was produced in (b)(6) 2022.The heater resistance was measured with an ohm meter to be 65.8 ohms.The heater resistance specification when cold is 62.23 ohms.Root cause of the sparks could not be determined as the returned device did not show evidence that it supported the customer's claim.The heater was replaced as a goodwill measure to resolve the issue.No further issues have been reported.
Event or Problem Description
It was reported that the users observed electrical sparking inside the device.It was confirmed that this did not lead to an injury for the patient.

• 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 ; 9784470587
• MDR Report Key: 17993536
• Report Number: 9611500-2023-00376
• Device Sequence Number: 6877195
• Product Code: FMT
• UDI-Device Identifier: 04049098000215
• UDI-Public: (01)04049098000215(11)100728(21)ZX06205(93)MU20503-30
• 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): 05/22/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2010
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown