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

Model Number 00-3020

Device Problem No Pacing (3268)

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

Event Date 06/23/2022

Event Type  Death  

Event Description

As described by the customer, the tempus ls failed to continually pace a 62 yo male who was in cardiac arrest.The patient was found in the front seat of a car and quickly moved to access the ls whilst cpr was in progress.The ls multipurpose pads were connected to the patient and the first rhythm present was a narrow complex bradycardic pea, which was later determined to be a3rd deg heart block.The 4 lead was connected and the ls was switched to pacer mode.External pacing was initiated and appeared to establish electric capture.Before a pulse could be palpated, the unit stopped pacing (for 5-10secs) and started flashing "hardware failure." further pacing was attempted a couple more times with the same result before the crew moved on to other treatment options.Later during the code, the patient degraded to v-fib and was successfully defibrillated twice without difficulty and malfunction.Patient pronounced dead at hospital.Device evaluation anticipated.

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 the device presented dpm hardware failure while pacing.Tempus ls failed continually pace the patient thais took place when treatment was being delivered to the patient in cardiac arrest.Further pacing was attempted a couple more times with the same result before the crew moved on to other treatment options.Later during the code, the patient degraded to v-fib and was successfully defibrillated twice without difficulty and malfunction.The patient was pronounced deceased at the hospital.Exchange replacement tempus ls defibrillator ordered and shipped to customer.The device logs and device was returned for investigation.Based on the log files the engineer confirmed error 26.Device arrived at (b)(4) for investigation.(b)(4) concluded that this issue is most likely due to an intermittent loss of communication between the dpm-board and the mainboard.As the issue is not clearly reproducible, the exact root cause cannot be determined.However, taking all components into account which are part of the communication path between the dpm-board and the mainboard, and which may cause an intermittent loss of communication, the source of the issue is most likely to be of a mechanical nature such as a connector.Therefore, it is suspected that the board-to-board connector between the dpm-board and the mainboard may be the root cause for this issue.As the root cause cannot be verified, (b)(4) cannot come to a conclusion.Based on the information available and the testing conducted, the cause of the reported problem was the display assembly.The reported problem was confirmed.A review of the risk management file was performed, and the potential severity is s has been identified in the risk document.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.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: tanya deschmidt ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 14985884
• MDR Text Key: 295678970
• Report Number: 3003832357-2022-00015
• 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

• 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: 06/23/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 06/23/2022
• Supplement Dates FDA Received: 12/01/2023
• 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): Death
• Patient Age: 62 YR
• Patient Sex: Male