MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC RESUSCITAIRE RADIANT WARMER; INFANT RADIANT WARMER

Catalog Number	MU20503
Medical Device Problem Codes	Device Handling Problem (3265); Suction Failure (4039)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Respiratory Insufficiency (4462); Insufficient Information (4580)
Date of Event	02/16/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that a baby was placed into a resuscitator and passed away due to the oxygen not being turned on by the users.
Additional Manufacturer Narrative
The investigation was started; results will be provided in a follow up-report.
Event or Problem Description
It was reported that a baby was placed into a resuscitator and passed away due to the oxygen not being turned on by the users.
Additional Manufacturer Narrative
Draeger was notified of the event when the hospital biomedical engineer requested application specialist training for users.On 26feb2024 draeger provided refresher training for 6 members of the staff.Additional information was provided from the associate director of nursing stating that the user did not fail to turn on the o2, the o2 was working during the resuscitation.Prior to the delivery, the resuscitaire was set up to receive the neonate with appropriate size equipment, and the operational checkout was completed successfully.However, during the event, when the consultant arrived, the junior doctors were in attendance and there was no pressure rise when delivering inflation breaths and the suction was not working.Therefore, a decision was made to move to an alternative resuscitaire.The baby was extremely premature and born in poor condition and there was no evidence there was a lack of oxygen as bmv (bag valve mask) was successful with oxygen.The hospital biomedical engineer evaluated the resuscitaire following the incident and found the equipment to be functioning correctly, no malfunctions were identified.Therefore, root cause cannot be determined.
Additional Manufacturer Narrative
Draeger was notified of the event when the hospital biomedical engineer requested application specialist training for users.On 26feb2024 draeger provided refresher training for 6 members of the staff.Additional information was provided from the associate director of nursing stating that the user did not fail to turn on the o2, the o2 was working during the resuscitation.Prior to the delivery, the resuscitaire was set up to receive the neonate with appropriate size equipment, and the operational checkout was completed successfully.However, during the event, when the consultant arrived, the junior doctors were in attendance and there was no pressure rise when delivering inflation breaths and the suction was not working.Therefore, a decision was made to move to an alternative resuscitaire.The baby was extremely premature and born in poor condition and there was no evidence there was a lack of oxygen as bmv (bag valve mask) was successful with oxygen.The hospital biomedical engineer evaluated the resuscitaire following the incident and found the equipment to be functioning correctly, no malfunctions were identified.Therefore, root cause cannot be determined.Update - 23jan2025 ¿ additional information was received from the customer stating that they received the postmortem report from the coroner which stated the patient died of natural causes.She was found to have a diaphragmatic eventration, left hypoplastic lung and was extremely premature.The diaphragmatic defect and the left hypoplastic lung explain why they were able to view chest movement when hand ventilating the baby due to the peep, and not via the resuscitaire.The coroner also added that the resuscitation would have been extremely difficult and would not likely succeed with these defects in addition to the baby¿s gestation.Based on this new information, a malfunction of the rescuscitaire can be excluded.
Event or Problem Description
It was reported that a baby was placed into a resuscitator and passed away due to the oxygen not being turned on by the users.

• Brand Name: RESUSCITAIRE RADIANT WARMER
• Common Device Name: INFANT RADIANT WARMER
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL INFANT CARE, INC.; 3135 quarry road; telford PA 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 9784097390
• MDR Report Key: 18787798
• Report Number: 2510954-2024-00005
• Device Sequence Number: 7832605
• Product Code: FMT
• UDI-Device Identifier: 04049098000215
• UDI-Public: (01)04049098000215(11)120515(93)MU20503-37
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2024
• Supplement Date Received by Manufacturer: 11/27/2024; 01/23/2025
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 11/27/2024; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2012
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown