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

Device Problems Defective Device (2588); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 03/28/2022

Event Type  malfunction  

Event Description

New philips tempus pro monitors and tempus ls defibrillator/pacemakers purchased.During a training session for our staff a tempus ls failed to electrically pace a simulated patient using a rhythm generator.Unit was reported to manufacturer philips case #(b)(4).Manufacturer took defective unit and replaced it with a new one.Serial numbers of units available upon request.Serial number (b)(4).Fda safety report id # (b)(4).

• Brand Name: TEMPUS LS DEFIBRILLATOR/PACEMAKERS
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): PHILIPS US/REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
• MDR Report Key: 14976728
• MDR Text Key: 295770011
• Report Number: MW5110785
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• 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: 04/05/2022
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: PHILIPS LS MONITOR