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

Model Number 00-3020

Device Problem Mechanical Problem (1384)

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

Event Date 08/12/2022

Event Type  malfunction  

Event Description

This report is based on information provided by schiller personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus ls manual indicating that device is not passing the pacer test, device will not pace over 20 ma during preventive maintenance.No patient involvement.Sales representative performed troubleshooting and confirmed the test setup is correct, issue has been isolated to the ls.Device received at schiller the manufacturer for investigation.Result son the logfile indicate that the issue appears to be caused by an error 26.Device shows an error message "defibrillator pacing module hardware failure."based on the investigation of the logfile, this error is caused due to communication error from the main board to the defibrillator pacing module.However, the actual root cause cannot be concluded at this stage.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.The customer was provided a replacement device to resolve the issue.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: TEMPUS LS-MANUAL
• Type of Device: 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 ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 17735933
• MDR Text Key: 323282263
• Report Number: 3003832357-2023-00586
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 00-3020
• Device Catalogue Number: 989706001681
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/12/2022
• 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
• Patient Outcome(s): Other