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

Model Number 00-3020

Device Problems Loose or Intermittent Connection (1371); Unable to Obtain Readings (1516)

Patient Problem Cardiac Arrest (1762)

Event Date 03/22/2023

Event Type  Injury  

Event Description

It has been reported to philips that while working a cardiac arrest, the monitor and ls were properly attached with pads and 3 lead.No rhythm was seen on either the monitor or ls.After a change in pads, there was still no rhythm seen on either screen.A user report was received related to a reported product problem which is currently being investigated.Further updates will be provided when the investigation is completed.

Manufacturer Narrative

This report is based on information provided by a philips remote service engineer, schiller (equipment manufacturer) and a rdt technical investigations engineer (remote diagnostic technologies) and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus ls and tempus pro indicating that no rhythm was observed on either device.This complaint is concerning investigation into the tempus ls.While the device was noted to be in use, there was reportedly no patient or user harm or impact.The reported complaint and good faith effort response from the customer states that pads and 3 lead were connected and that with a change to new good pads still no rhythm was observed.Diagnostics determined the device would require return for investigation and the tempus ls was received at schiller where a technical investigation was completed.The device was tested and found to be functioning satisfactorily.The device worked as intended.The returned device was removed from service and processed following local procedures.A technical investigation was completed at rdt to review the log and rescue files for impedance results.The event described by the customer was observed as the impedance measured by the pads was less less than 25 o, logs also indicate unplug and plug of pads (as user described as change of pads), the impedance measured was still less than 25 o even after a change of pads.The tempus ls displays "check defibrillator electrodes".This message is reported when the impedance range falls outside the acceptable range per the manual (25 o-250 o).When the impedance measurement is out of range (less than 25o and or greater than 250o), tempus ls does not display the ecg signals.Based on the information available and testing conducted, the cause of the reported problem is unknown, the device functioned satisfactorily and no problem was found with the device.The reported problem was not confirmed.Based on the information available, further action is necessary at this time.While no harm was alleged, recurrence of this failure mode during clinical use could cause or contribute to death or serious injury.Therefore, this failure mode meets the definition of a reportable malfunction.Appropriate regulatory reporting actions have been taken.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: 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: 16918306
• MDR Text Key: 315072250
• Report Number: 3003832357-2023-00299
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• 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
• Date Manufacturer Received: 04/17/2023
• 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