MAUDE Adverse Event Report: MEDTRONIC, INC. CARDIAC PULSE OX MONITORS; OXIMETER

Device Problem Defective Alarm (1014)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Increased Respiratory Rate (2486)

Event Date 01/30/2020

Event Type  malfunction  

Event Description

The hospital has experienced three separate events within the past several weeks regarding our cr pulse ox monitors.Event 1 - picu-staff member watching monitor and noticed patient's blood pressure per the arterial line monitoring had decreased significantly, but no alarms had alerted to the issue.When the staff checked the monitor setup, all the arterial lines monitoring alarms were turned off.Not sure how long the blood pressure was down but did have to escalate patient's vasoactive drip.Event 2 - inpatient unit-patient had tachypnea/tachycardia.Patient has abnormal baseline, and it was difficult for both medical and nursing teams to understand what was occurring with the patient and whether there was a problem with the cardiac monitor.Event 3 - inpatient unit-pediatric patient admitted for bacterial pneumonia.Hospitalist was paged by nurse stating that cr monitor was alarming v-tach.Patient assessed and was well appearing.Stat ekg ordered, and patient was in normal sinus rhythm.Per nursing, hospital is transitioning to new cr monitors.It is concerning that cr monitor was incorrectly alarming for an abnormal rhythm.Of note, cr monitor was not ordered at the time of admission, and patient should not have been on a cr monitor.

Event Description

The hospital has experienced three separate events within the past several weeks regarding our cr pulse ox monitors.Event 1-picu-staff member watching monitor and noticed patient's blood pressure per the arterial line monitoring had decreased significantly, but no alarms had alerted to the issue.When the staff checked the monitor setup, all the arterial lines monitoring alarms were turned off.Not sure how long the blood pressure was down but did have to escalate patient's vasoactive drip.Event 2-inpatient unit-patient had tachypnea/tachycardia.Patient has abnormal baseline, and it was difficult for both medical and nursing teams to understand what was occurring with the patient and whether there was a problem with the cardiac monitor.Event 3-inpatient unit-pediatric patient admitted for bacterial pneumonia.Hospitalist was paged by nurse stating that cr monitor was alarming v-tach.Patient assessed and was well appearing.Stat ekg ordered, and patient was in normal sinus rhythm.Per nursing, hospital is transitioning to new cr monitors.It is concerning that cr monitor was incorrectly alarming for an abnormal rhythm.Of note, cr monitor was not ordered at the time of admission, and patient should not have been on a cr monitor.

• Brand Name: CARDIAC PULSE OX MONITORS
• Type of Device: OXIMETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 9888440
• MDR Text Key: 185223594
• Report Number: 9888440
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 120 DA