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

Model Number 00-3020

Device Problems Loose or Intermittent Connection (1371); 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.

Manufacturer Narrative

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

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

Manufacturer Narrative

This report is based on information provided by philips remote service engineer and schiller investigation team and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus ls indicating that device failed to show ecg waveforms even after pads were switched out, requesting exchange part.Rdt informed schiller ag the manufacturer , that the patient involved in this case died.The device was used initially in this intervention and was not able to record any ecg signal.The device was arrived at schiller ag on 2022-07-12 and was tested successfully with no device failure found.The internal tests and investigation showed that the device worked as intended.No malfunctions were discovered.The log-files and the rescue-files show the same data: it seems that the device was working correctly.It is not clear why the pads ecg was only recorded for 2s, but the device correctly detected the disconnection and displayed ¿check defibrillation electrodes¿ as intended.As no malfunctions were discovered, the disconnects must be related either to the defibrillator pads or patient's condition.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.If additional information is received the complaint file will be reopened.

• 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: jon yard ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 14834263
• MDR Text Key: 302847086
• Report Number: 3003832357-2022-00011
• 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

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
• Supplement Dates FDA Received: 07/19/2022; 07/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2021
• 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): Death; Other