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

Catalog Number	MS25510
Medical Device Problem Code	Inaudible or Unclear Audible Prompt/Feedback (2283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was started; results will be provided in a follow up-report.
Event or Problem Description
It was reported that the patient had desaturations down to 5% and bradycardia down to 23%.The nurse was near the baby¿s cot side and writing her notes and she could not hear the alarm.Father of another baby alerted nurse to check the baby when he saw both red lights flashing on the monitor.
Additional Manufacturer Narrative
It was reported that the patient had desaturations down to 5% and bradycardia down to 23%.A guest alerted the nurse of red lights flashing at the cockpit, as the nurse could not hear the alarms.A root caused cannot be determined, as the logs provided did not provide details encompassing the date of event.It is possible that the audio was muted from the bedside by another user.It is also possible that the cockpit volume was too low to be heard over other devices in the room.However, without the logs at the time of the event, the root cause cannot be determined.
Event or Problem Description
It was reported that the patient had desaturations down to 5% and bradycardia down to 23%.The nurse was near the baby¿s cot side and writing her notes and she could not hear the alarm.Father of another baby alerted nurse to check the baby when he saw both red lights flashing on the monitor.

• 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
• Manufacturer Contact: 3135 quarry road; telford, PA ; 9784470587
• MDR Report Key: 18552580
• Report Number: 1220063-2024-00007
• Device Sequence Number: 7597544
• Product Code: MHX
• UDI-Device Identifier: 04049098054409
• UDI-Public: (01)04049098054409(11)171020(17)180205(93)MS25510-45
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

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: MS25510
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2017
• 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