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

Device Problems Failure to Deliver Shock/Stimulation (1133); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2022

Event Type  Injury  

Event Description

During resuscitative efforts of a cardiac arrest patient, the tempus ls failed to provide electrical tracing and therapy through the therapy electrodes.These therapy electrodes were a new set placed after multiple defibrillations of the patient.The monitor did charge appropriately, but when the defibrillate button was pressed it failed to do so.The previously used therapy pads were reconnected to the tempus ls and functioned normally for the duration of the resuscitative effort.

• Brand Name: PHILIPS TEMPUS LS
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC
• MDR Report Key: 15987006
• MDR Text Key: 305527065
• Report Number: MW5113792
• Device Sequence Number: 1
• 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: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 49 YR
• Patient Weight: 130 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American