MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC TRANSPORT INCUBATOR 500 GLOBETROTTER; INCUBATOR, NEONATAL TRANSPORT

Catalog Number	MU20508
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has started.A follow up report will be submitted upon completion.
Event or Problem Description
It was reported by the customer that on (b)(6) 2024 the transport incubator 500 (ti500) globe trotter had an issue with the temperature adjust button and the ventilator had an issue maintaining pressure.There was no adverse patient effects reported.The device was inspected and serviced by draeger engineering and found that the reported problems only occurred intermittently.The issue related to the unresponsive temperature adjust button was confirmed during draeger's inspection of the device.Drager service followed service software for repair instructions and replaced the temperature controller to resolve the issue.The customer's concern with the ventilator not holding pressure was not able to be reproduced during service.The device was tested and confirmed to have been operating per the manufacturer's specifications.
Additional Manufacturer Narrative
A complaint was received on (b)(6) 2024 regarding a transport ti500 globetrotter that did not respond to the temperature adjust button.The customer also expressed concerns with the ventilator not holding pressure.The device was in use when the issue occurred, however, there was no patient injury reported.Additional information was requested from the customer regarding this event.The customer confirmed that there were no alarms when the issue occurred and the issue with the temperature adjust button was intermittent.The issue with the ventilator was only observed once.Further information regarding the status of the patient was requested but not provided.Additionally, the customer confirmed that preventative maintenance had not been performed on this device.On (b)(6) 2024 the device was service by draeger.The reported problem with the ventilator was unable to be replicated, however the issue with the temperature adjust button was confirmed.The draeger service repair instructions were followed to repair the device and replacement parts were ordered.On 16oct2024 the temperature control panel assembly was replaced along with the overlay front panel.Following the repair, the device was tested and confirmed to operate per the manufacturer's specification.The unit was handed back to the customer for clinical use.It was noted that if the ventilation issue were to recur and could be duplicated, the vent would be sent to biomed services for evaluation.The instructions for use (ifu), section 4, "installation and functional checkout," instructs the user to ensure proper function of the device prior to being put into clinical use and section 6, "cleaning, maintenance, and replacement parts," provides guidance for the user to perform preventative maintenance at the specified intervals.The ifu states that pneumatic module should have preventative maintenance performed every 12 months.A specific root cause for the intermittent fault of the temperature adjust button and the ventilator could not be confirmed in this investigation.A replacement of the temperature control assembly and the overlay front panel resolved the reported issue.
Event or Problem Description
It was reported by the customer that the on (b)(6) 2024 the transport incubator 500 (ti500) globe trotter had an issue with the temperature adjust button and the ventilator had an issue maintaining pressure.There was no adverse patient effects reported.The device was inspected and serviced by draeger engineering and found that the reported problems only occurred intermittently.The issue related to the unresponsive temperature adjust button was confirmed during draeger's inspection of the device.Drager service followed service software for repair instructions and replaced the temperature controller to resolve the issue.The customer's concern with the ventilator not holding pressure was not able to be reproduced during service.The device was tested and confirmed to have been operating per the manufacturer's specifications.

• Brand Name: TRANSPORT INCUBATOR 500 GLOBETROTTER
• Common Device Name: INCUBATOR, NEONATAL TRANSPORT
• 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 ; 9784090504
• MDR Report Key: 20545945
• Report Number: 2510954-2024-00047
• Device Sequence Number: 7532417
• Product Code: FPL
• UDI-Device Identifier: 04049098000192
• UDI-Public: (01)04049098000192(11)140226(93)MU20508-23
• Combination Product (Y/N): N
• PMA/510(K) Number: K941106
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: MU20508
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown