MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC DELTA; PHYSIOLOGICAL MONITORING SYSTEMS

Catalog Number	MS18597
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer is requesting a dispatch on their delta since the screen went black in the middle of a case and they were not able to get it back on until this morning.No patient injury.The monitor was switched out during case.
Additional Manufacturer Narrative
The 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 that customer is requesting a dispatch on their delta since the screen went black in the middle of a case and they were not able to get it back on until this morning.No patient injury.The monitor was switched out during case.
Additional Manufacturer Narrative
A complaint was submitted where it was reported that the delta screen went black in the middle of a case.The draeger technician verified that the cited monitor was not docked properly to the infinity docking station (ids) and therefore it was not receiving ac power.As a result, the delta monitor was running on the devices internal battery.The cause of the issue was due to the internal battery power becoming completely depleted which caused the delta to shut down.Several requests were made to determine if the monitor alarmed while it was running on battery power at 10% and 5% of capacity and then a final alarm when the battery was completely depleted.This information could not be provided.The customer confirmed the delta monitor operated as intended when it was properly docked to the ids.The delta has been returned to use with no further issues or errors reported.

• Brand Name: DELTA
• Common Device Name: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS INC; 6 tech drive; andover MA
• Manufacturer Contact: 6 tech drive; andover, MA ; 2156602400
• MDR Report Key: 18487555
• Report Number: 1220063-2024-00002
• Device Sequence Number: 17906648
• 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): 02/21/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2013
• 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
• Patient Sex: Unknown