MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Catalog Number	MS26372
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that on standalone m540, the spo2 waveform and numeric values dropped on (b)(6).At 10:30 am while using masimo rainbow pods on a neonatal patient.It was reported that the m540 would display that it was "searching" for an sp02 value, but that the waveform would flatline and no numerical values could be shown.No patient injury or death was reported.
Event or Problem Description
It was reported that on standalone m540, the spo2 waveform and numeric values dropped on 03/28 at 10:30 am while using masimo rainbow pods on a neonatal patient.It was reported that the m540 would display that it was "searching" for an sp02 value, but that the waveform would flatline and no numerical values could be shown.No patient injury or death was reported.
Additional Manufacturer Narrative
The customer reported that the spo2 waveform and numeric values drop intermittently at the customer site in multiple rooms.The provided m540 logs were reviewed but showed the device was in standby mode during the date/time specified (february 28th at 10:30am).Images and/ or videos of the error were requested multiple times, but not provided.Therefore, the root cause nor the issue can be confirmed.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• 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 ; 2156602400
• MDR Report Key: 19181875
• Report Number: 1220063-2024-00048
• Device Sequence Number: 18000054
• Product Code: MHX
• UDI-Device Identifier: 04049098009751
• UDI-Public: (01)04049098009751(11)220505(93)MS26372-56
• Combination Product (Y/N): N
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: MS26372
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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: Other
• Patient Sex: Unknown