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

Model Number 00-3020

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2022

Event Type  Injury  

Event Description

Customer reported tempus ls failed to recognize ecg while used during cardiac arrest.Changed pads and electrodes to troubleshoot with no changes and was unable to acquire clear results.A user report was received related to a reported product problem which is currently being investigated.At the time of reporting, the device has not yet been returned for investigation.Further updates will be provided when the device is received, and the investigation is in progress.

Manufacturer Narrative

Corrected the product problem to serious injury.

Manufacturer Narrative

This report is based on information provided by 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 recognize ecg while using during cardiac arrest.Customer changed pads and electrodes to trouble shoot with no changes but unable to acquire clear result the schiller manufacturer confirmed that the reported problem was unconfirmed.Full disclosure report involving , shows that no ecg was captured with the tempus ls (both ecg signals were from the tempus pro)4 instances of pads being attached and detached, 1 second apart.Device worked as intended but there was a problem with the pads or with applying the pads as per the review of the log file.Based on the logs analysis it was concluded that the device was working as intended.The device was never in monitor mode, that is why ecg lead ii was never seen on the tempus ls.It is unclear why the pads were connected and disconnected.The device was never set to monitor mode, which explains why the ecg lead ii was never seen on the tempus ls.Schiller confirmed it was a normal behaviour and the device worked as intended.It was never set to monitor mode, which explains why the ecg lead ii was never seen on the tempus ls.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.

• Brand Name: TEMPUS LS-MANUAL
• Type of Device: LOW ENERGY DEBFIBRILLATOR
• Manufacturer (Section D): SCHILLER AG; altgasse 68; baar 6341 ; SZ 6341
• Manufacturer (Section G): SCHILLER AG; altgasse 68; baar 6341 ; SZ 6341
• Manufacturer Contact: rekha rv ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 15795823
• MDR Text Key: 303626678
• Report Number: 3003832357-2022-00047
• 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: 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?: No
• 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: 10/17/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 10/17/2022; 10/17/2022
• Supplement Dates FDA Received: 02/10/2023; 03/09/2023
• 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; Life Threatening