MAUDE Adverse Event Report: DRAEGER MEDICAL INFANT CARE, INC. ISOLETTE 8000; INFANT INCUBATOR WITH OXYGEN, SCALE AND HUMIDITY

Model Number	MU20600
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Event or Problem Description
It was reported the nurse noticed that one of the side doors (hand port) of the dräger isolette 8000 infant incubator was open and part of the newborn's body was sticking out through the door.According to them, the baby is a rather hyperactive child and it is suspected that he may have kicked the door of the incubator from the inside and it opened as a result.The incubator door had been open once before, but the child did not hang out then.The incident was recorded and fortunately no accident occurred.
Event or Problem Description
It was reported the nurse noticed that one of the side doors (hand port) of the dräger isolette 8000 infant incubator was open and part of the newborn's body was sticking out through the door.According to them, the baby is a rather hyperactive child and it is suspected that he may have kicked the door of the incubator from the inside and it opened as a result.The incubator door had been open once before, but the child did not hang out then.The incident was recorded and fortunately no accident occurred.
Additional Manufacturer Narrative
A draeger technician went on site and the latch of the cited hand port had already been replaced by the hospital biomed.It was noted by the biomed and confirmed by the draeger technician that the original latch that was replaced was cracked, broken and damaged.Though damage of the latch was identified, testing of the latch was not performed by the biomed prior to it being replaced and no further testing of the latch was performed due the damaged state.Therefore, we cannot determine if the damage impacted the function of the latch during the reported event.To ensure the replacement latch functioned per specifications, the draeger technician performed the required testing.Although initially it was reported that the 4th time the test was performed, it failed, this was a misunderstanding.Review of the videos provided and further communication with the draeger technician confirmed the test passed every time and the replacement latch is working as intended.Once the device passes the required pressure test, the device is found to comply with recommended standards forces to maintain patient barrier closure (iec 60601-2-19: medical electrical equipment ¿ part 2-19: particular requirements for the basic safety and essential performance of infant incubators).No further issues have been reported.

• Brand Name: ISOLETTE 8000
• Common Device Name: INFANT INCUBATOR WITH OXYGEN, SCALE AND HUMIDITY
• Manufacturer (Section D): DRAEGER MEDICAL INFANT CARE, INC.; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL INFANT CARE, INC.; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA
• MDR Report Key: 16732508
• Report Number: 2510954-2023-00002
• Device Sequence Number: 20498981
• Product Code: FMZ
• UDI-Device Identifier: 04049098000178
• UDI-Public: 04049098000178
• Combination Product (Y/N): N
• PMA/510(K) Number: K001242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2023

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 Model Number: MU20600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2013
• 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