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

Model Number 00-3020

Device Problems Electrical /Electronic Property Problem (1198); Insufficient Information (3190); Intermittent Communication Failure (4038)

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

Event Date 08/01/2022

Event Type  Injury  

Event Description

As described by the customer 'during cardiac arrest user charged and shocked the patient with no issues.User charged the unit to deliver a 2nd shock and tempus ls displayed "hardware failure" message and would not deliver the 2nd shock'.User attached another defib to patient and continued to provide care.Philips rdt planning to receive the device and send to the manufacturer for the root cause investigation.

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 hardware failure message during cardiac arrest.Based on the evidence available the reported problem was confirmed.The communication between host and dpm was disturbed.The source of the disturbance cannot be concluded at this stage, as the device is not available physically for investigation.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.

Event Description

As described by the customer 'during cardiac arrest user charged and shocked the patient with no issues.User charged the unit to deliver a 2nd shock and tempus ls displayed "hardware failure" message and would not deliver the 2nd shock'.User attached another defib to patient and continued to provide care.

Event Description

As described by the customer 'during cardiac arrest user charged and shocked the patient with no issues.User charged the unit to deliver a 2nd shock and tempus ls displayed "hardware failure" message and would not deliver the 2nd shock'.User attached another defib to patient and continued to provide care.Results of the investigation on log files by the manufacturer schiller: the reason that ¿hardware failure (dpm)¿ will be shown - the dpm normally sends a status frame every 100 ms.In case no valid frame can be processed within 250 ms the dpm is reinitialized.This normally does not happen.No valid frame means either the dpm did not send a frame or data was received but it was not a valid frame (checksum wrong or unexpected data or incomplete).In case this happens more than 3 times the ¿hardware failure (dpm)¿ is displayed.About 20 minutes after the first display of ¿hardware failure (dpm)¿ the device was shut down.The log received at least 3 corrupted frames that had at least unexpected header or tail bytes and a wrong crc.So it looks like in this particular setup, the communication between host and dpm was disturbed.The next time the device was started up was at the next day at 2 am for self test that passed successful.All self tests from 4th april to 2th august passed successfully.When a patient is connected, the electrical conditions are different than when an emulator is connected.From the point of view of the sw, however, there is no difference whether a patient or emulator is connected.Therefore, this indicates a hardware problem.The crc errors on the serial connection also clearly indicate that the electrical transmission is disturbed.It is difficult to say whether it is a general problem or a specific problem of this device.This would have to be checked by a test setup that corresponds to the situation in which the error occurred.If it is not possible to communicate with the dpm, then defibrillation cannot be performed.Philips rdt planning to receive the device and send to the manufacturer for the root cause investigation.

• 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: selvaganesan balu ; ascent 1, aerospace centre; aerospace boulevard; farnborough ; UK
• MDR Report Key: 15322129
• MDR Text Key: 303631141
• Report Number: 3003832357-2022-00022
• 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
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• 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
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/20/2021
• 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): Other