MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA DELTA; PHYSIOLOGICAL MONITORING SYSTEMS

Catalog Number	MS18597
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.
Event or Problem Description
It was reported to dräger that device reboots occur randomly for no obvious reason and that this affects more than one device.Patient monitoring was always continued after the reboot.It was confirmed to dräger that the reported issue did not lead to patient consequences.
Event or Problem Description
It was reported to dräger that device reboots occur randomly for no obvious reason and that this affects more than one device.Patient monitoring was always continued after the reboot.It was confirmed to dräger that the reported issue did not lead to patient consequences.
Additional Manufacturer Narrative
A complaint was submitted where it was reported that two delta monitors restarted multiple times.The available ics logs were analyzed by draeger engineering, and they confirm there were two delta monitors that restarted.The reason for the restart could not be confirmed in the ics logs.The logs from both the delta monitors that restarted along with a network wireshark capture would be needed to further investigate the cause of the issue.Unfortunately, they were unavailable for this investigation.It was confirmed that patient monitoring always continued after the ics restart.It was confirmed to dräger that the reported issue did not lead to any patient consequences.Service has confirmed with the site that they have not been able to duplicate the issue or had seen the issue with their own eyes.Should there be a reoccurrence of the delta restarting provide all the ics logs, the delta logs and a network wireshark capture covering the date and time of the issue.

• Brand Name: DELTA
• Common Device Name: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 17973486
• Report Number: 9611500-2023-00374
• Device Sequence Number: 7035758
• Product Code: MHX
• UDI-Device Identifier: 04049098004152
• UDI-Public: 04049098004152
• Combination Product (Y/N): N
• PMA/510(K) Number: K152407
• Number of Events Summarized: 1
• Summary Report (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): 05/06/2024

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: MS18597
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2010
• 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