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

Model Number 00-3020

Device Problems Loose or Intermittent Connection (1371); Unable to Obtain Readings (1516)

Patient Problem Unspecified Heart Problem (4454)

Event Date 04/24/2023

Event Type  Injury  

Event Description

It has been reported to philips that the device would not capture the patient's rhythm due to the device not reading the pads.Pads were replaced and the issue remained.There is no known 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: jon yard ; altgasse 68; baar 6341 ; SZ 6341 ; 0417664242
• MDR Report Key: 16910964
• MDR Text Key: 314995609
• Report Number: 3003832357-2023-00298
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 07613365002737
• UDI-Public: 7613365002737
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00-3020
• Device Catalogue Number: 989706001681
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2023
• 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
• Patient Outcome(s): Other