MAUDE Adverse Event Report: PHILLIPS / REMOTE DIAGNOSTIC TECHNOLOGIES LTD. TEMPUS LS DEFIBRILLATOR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Device Problems Product Quality Problem (1506); Device Sensing Problem (2917)

Patient Problem Cardiac Arrest (1762)

Event Date 10/15/2022

Event Type  Injury  

Event Description

During the resuscitation of a cardiac arrest patient, the tempus ls failed to provide an ecg tracing via the defibrillator electrodes.Providers on scene attempted to deploy a total of 3 defibrillator electrodes across two tempus ls devices without success.Multiple providers on scene have extensive experience utilizing the product and managing high acuity patients.Troubleshooting efforts were unsuccessful and ultimately the cardiac arrest had to be managed utilizing an aed.It was noted after the call that all defibrillator electrodes were from the same lot number.Analysis of the data following the call revealed multiple messages in the monitor indicated "pads attached" and "pads detached" in rapid sequence.At times these messages were occurring 3-4 times a second.Fda safety report id #(b)(4).

• Brand Name: TEMPUS LS DEFIBRILLATOR
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): PHILLIPS / REMOTE DIAGNOSTIC TECHNOLOGIES LTD.; cambridge MA 02141
• MDR Report Key: 15744487
• MDR Text Key: 303301366
• Report Number: MW5113097
• Device Sequence Number: 2
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/03/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR
• Patient Sex: Male