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

Model Number	N/A
Medical Device Problem Codes	Gas Output Problem (1266); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/09/2024
Type of Reportable Event	Death
Event or Problem Description
The customer reported that a premature infant required immediate medical intervention using a resuscitator.Reportedly, both the maternity and neonatal teams had checked the equipment before use, confirming that it was functioning properly.During the process of giving breaths and suction to the newborn, the resuscitator suddenly stopped working.The maternity team reported that either the oxygen or air cylinder had not been turned on.Meanwhile, and the neonatal team reported that one of the cylinders was empty.The infant was stabilized and brought to the neonatal intensive care unit.The patient's condition deteriorated overnight, and the patient passed away.
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.
Additional Manufacturer Narrative
A complaint was received regarding the resuscitaire during use of suction to the newborn, suddenly stopped working.The site investigation identified the cause as either the oxygen or air cylinder was not turned on, or one of the cylinders (oxygen or air) was empty.Further information was requested but not provided.Based on the information provided, there was no device malfunction.The resuscitaire information for use has a warning: if either the air or oxygen gas source pressure is reduced, creating a pressure differential of 207 kpa (30 psi), the microblender alarm sounds.This condition can alter the fio2 and flow output from the microblender.Patient injury could occur.
Event or Problem Description
The customer reported that a premature infant required immediate medical intervention using a resuscitaire.Reportedly, both the maternity and neonatal teams had checked the equipment before use, confirming that it was functioning properly.During the process of giving breaths and suction to the newborn, the resusitaire suddenly stopped working.The maternity team reported that either the oxygen or air cylinder had not been turned on.Meanwhile, and the neonatal team reported that one of the cylinders was empty.The infant was stabilized and brought to the neonatal intensive care unit.The patient's condition deteriorated overnight, and the patient passed away.

• Brand Name: RESUSCITAIRE RADIANT WARMER
• 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 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 9784828529
• MDR Report Key: 20351272
• Report Number: 2510954-2024-00043
• Device Sequence Number: 18148694
• Product Code: FMT
• UDI-Device Identifier: 04049098000215
• UDI-Public: (01)04049098000215(11)191104(17)211031(93)MU20503-55
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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 Model Number: N/A
• Device Catalogue Number: MU20503
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2019
• 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: Death
• Patient Sex: Unknown