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

Model Number 00-3020

Device Problems Mechanical Problem (1384); Failure to Analyze Signal (1539)

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

Event Date 06/14/2022

Event Type  malfunction  

Event Description

It has been reported that the device's ecg port is loose is and the device therefore cannot give an ecg signal.There is no patient involvement.

Manufacturer Narrative

Date mfr received updated to 06mar2024 originally provided on mfr #.

Manufacturer Narrative

Updated conclusion code and evaluation result code.

• Brand Name: TEMPUS LS MANUAL
• 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: tanya deschmidt ; altgasse 68; baar 6341 ; SZ 6341 ; 0417664242
• MDR Report Key: 17978241
• MDR Text Key: 326188650
• Report Number: 3003832357-2023-00722
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 07613365002737
• UDI-Public: 07613365002737
• 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,Followup,Followup,Followup

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 10/02/2023; 03/06/2024; 03/06/2024
• Supplement Dates FDA Received: 03/25/2024; 04/03/2024; 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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