MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC VISTA XL; PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Catalog Number	MS18986
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Cyanosis (1798)
Date of Event	06/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that on (b)(6) 2024, after the patient's surgery and extubation, the oxygen saturation reading showed significant interference and the device reportedly did not trigger any alarms.The doctor noticed cyanosis around the patient¿s mouth and lips, intervened promptly by providing assisted breathing treatment, and the patient's condition improved immediately.The issue was identified in time and did not result in significant harm to the patient.It was reported that the spring of the pulse oximeter had malfunctioned.
Event or Problem Description
The customer reported that on (b)(6) 2024, after the patient's surgery and extubation, the oxygen saturation reading showed significant interference and the device reportedly did not trigger any alarms.The doctor noticed cyanosis around the patient¿s mouth and lips, intervened promptly by providing assisted breathing treatment, and the patient's condition improved immediately.The issue was identified in time and did not result in significant harm to the patient.It was reported that the spring of the pulse oximeter had malfunctioned.
Additional Manufacturer Narrative
A complaint was submitted where it was reported that the oxygen saturation reading showed significant interference along with data loss and no alarms during a surgical procedure.The cause of the reported issue was due to to a faulty finger pulse oximeter probe where the spring failed which impacted the detection accuracy of the probe.When the finger probe was replaced the vista xl operated without error.Furthermore, it was confirmed that during this incident the probe in use was not a draeger product.The customer used a different manufacture for the finger probe.The ufr reports that the oxygen saturation interfered with medical judgment due to the reported issue with the faulty finger probe.The patient's lips reportedly turned slightly purple and the monitor did not alarm.The doctor found the patient's lips were cyanotic, and timely intervention was made as the patient was given assisted breathing treatment and their condition immediately improved.This issue was discovered in time and did not cause great harm to the patient.It has been confirmed by the customer that the patient is currently in good condition.The root cause of the reported issue where the oxygen saturation showed interference with data loss and no alarms, was due to a poor connection with a faulty finger pulse oximeter probe.The faulty finger probe was found to be operating incorrectly due to faulty spring.The ifu states the user should check for any damage to all parts prior to use and to only use draeger products and approved accessories.There have been no additional faults or errors reported from the customer's site.

• Brand Name: VISTA XL
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA

9784828529

• MDR Report Key: 19883125
• Report Number: 1220063-2024-00095
• Device Sequence Number: 7077524
• Product Code: MHX
• UDI-Device Identifier: 04049098003858
• UDI-Public: (01)04049098003858(11)140613(93)MS18986
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MS18986
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown