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

Model Number 00-3020

Device Problems Electrical /Electronic Property Problem (1198); Fitting Problem (2183); Device Handling Problem (3265)

Patient Problems Cardiac Arrest (1762); Insufficient Information (4580)

Event Date 04/12/2022

Event Type  Death  

Event Description

As customer described 'no ecg waveforms even after pads were switched out, requesting exchange part'.Philips rdt planning to receive the device and send to the manufacturer for the root cause investigation.

Event Description

As customer described 'no ecg waveforms even after pads were switched out, requesting exchange part'.Philips rdt planning to receive the device and send to the manufacturer for the root cause investigation.Additional information has been received regarding this event on (b)(6) 2022 - it has been confirmed that the patient involved died.

Manufacturer Narrative

Additional information has been received regarding this event on 5th july 2022 - it has been confirmed that the patient involved died.

Manufacturer Narrative

Philips received a complaint on the tempus ls indicating no appearance of ecg waveforms even after pads were switched out.The device arrived at schiller the manufacturer on 2022-07-12 and was tested successfully with no device failure found.The device was operated in manual mode during the entire intervention.Therefore, the customer was reported about the pad ecg.The log-files and the rescue-files show the same data as no problem in the device.It was concluded that the device was working correctly.It is not clear why the pads ecg lost connection, but the loss of connection was detected by the device and the device state always ¿check defibrillation electrodes¿.No malfunction was detected during internal testing and there was no visible damage on the device.Based on the available information, the device worked as intended and did not contribute to the loss of connection.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 investigation concludes that no further action is required at this time.

Manufacturer Narrative

Updated problem code grid to reflect investigation results provided on mfr #3003832357-2022-00010.

• 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 ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 14834215
• MDR Text Key: 296678650
• Report Number: 3003832357-2022-00010
• 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: User Facility
• 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?: Yes
• 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: 04/12/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 04/12/2022; 04/12/2022; 11/15/2022
• Supplement Dates FDA Received: 07/19/2022; 08/24/2023; 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other