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

Device Problem Pacing Problem (1439)

Patient Problem Bradycardia (1751)

Event Date 09/29/2022

Event Type  Injury  

Event Description

Following the resuscitation of a cardiac arrest patient, the patient was noted to become bradycardic to the point of requiring external pacing.The monitor was engaged into pacing mode but failed to begin pacing.Retrospective analysis of ecg data reveals multiple messages of "pads attached, pads detached" despite no disconnection of the therapy pads.Fda safety report id# (b)(4).

• Brand Name: PHILIPS TEMPUS LS DEFIBRILLATOR
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC
• MDR Report Key: 15753859
• MDR Text Key: 303310854
• Report Number: MW5113113
• 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: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White