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

Model Number 00-3020

Device Problems Circuit Failure (1089); No Pacing (3268)

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

Event Date 12/08/2021

Event Type  Death  

Manufacturer Narrative

A user report was received related to a reported patient death 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 investigation has progressed.

Event Description

The incident described as follows by the customer - reports on (b)(6) 2021, while on a call with the device, patient had hr 30, got a pacer failure, and patient arrested/expired.Patient was (b)(6) male that was unresponsive.Ecg applied/noted hr 30, attempted to pace the patient x3 without success and patient went into cardiac arrest/expired.While attempting to pace the patient, it would work for short amount of time after plugging in the cables, then stop working, plug in again and same thing.

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 pace.Based on the evidence available the reported problem was unconfirmed.Functional analysis : recorded data from the full disclosure report (b)(4) shows that the patient was treated with the external pacemaker.The pacemaker was stopped and the ecg rhythm still shows a very low hr.The pacemaker is restarted, after stopping again the ecg rhythm shows asystole.The unit was then set to manual defibrillation mode, but no shock was delivered.Cpr was started, cpr was stopped, and the ecg rhythm again showed a deep hr.Cpr was resumed.This was but the patient never changed to a stable ecg rhythm and no shock was delivered.It must be assumed that the patient was dying and therefore cpr no longer had any effect and no shockable rhythm was achieved.Why the user reported a problem with the ecg recording (ecg cables, not pads) cannot be deduced from these recordings.However, it could well be that contact with the ecg electrodes became poor during dying and therefore the ecg recording was interrupted.The recording of the ecg via the pads was always given.Based on the log files and the pdf, an user error is assumed.Ecg cable had fallen off according to log files.Cause: pads disconnected during use or user does not connect pads correctly 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: selvaganesan balu
• MDR Report Key: 13117684
• MDR Text Key: 282960659
• Report Number: 3003832357-2021-10007
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2021
• 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): Death
• Patient Age: 58 YR
• Patient Sex: Male