MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC. TEMPUS LS MAN DEFIBRILLATOR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number 98587027

Device Problems Unable to Obtain Readings (1516); Failure to Sense (1559)

Patient Problem Cardiac Arrest (1762)

Event Date 10/15/2022

Event Type  Injury  

Event Description

During the resuscitation of a cardiac arrest patient, the philips 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 (automated external defibrillator).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 MAN DEFIBRILLATOR
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC.
• MDR Report Key: 15673395
• MDR Text Key: 302484736
• Report Number: MW5112840
• Device Sequence Number: 3
• 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: 10/21/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 98587027
• Device Catalogue Number: 989706001681
• Device Lot Number: Y110821-05
• 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
• Patient Ethnicity: Hispanic
• Patient Race: White