MAUDE Adverse Event Report: SCHILLER AG TEMPUS LS; LOW ENERGY DEFIBRILLATOR

Model Number 00-3020

Device Problem Failure to Analyze Signal (1539)

Patient Problem Cardiac Arrest (1762)

Event Date 04/19/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the user was unable to get an ecg on the tempus pro monitor using multiple sets of pads during a patient use event.The user eventually wiped down and moistened the patient's skin and were eventually able to get a reading.There is no reported impact or consequence to the patient.

• Brand Name: TEMPUS LS
• Type of Device: LOW ENERGY DEFIBRILLATOR
• Manufacturer (Section D): SCHILLER AG; altgasse 68; baar 6341 ; SZ 6341
• Manufacturer (Section G): SCHILLER AG; altgasse 68; baar 6341 ; SZ 6341
• Manufacturer Contact: dana tackett ; altgasse 68; baar 6341 ; SZ 6341 ; 0417664242
• MDR Report Key: 16855994
• MDR Text Key: 314413084
• Report Number: 3003832357-2023-00271
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

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
• Device Model Number: 00-3020
• Device Catalogue Number: 989706001681
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1