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

Model Number 00-3020

Device Problem Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

As described by the customer 'failed to deliver shock while being used for training and when hooked to a simulator'.A user report was received related to a failure to deliver shock 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 has progressed.

Manufacturer Narrative

This report is based on information provided by philips schiller personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus ls indicating that the device failed to deliver shock while being used for training and when hooked to a simulator.The complaint was escalated for technical investigation and the results indicate that the root cause could not clearly be determined.Repair department reported that the device passed the incoming tests.However, after running a pacer test during the weekend, they noticed the following issue on the unit: "after the long-term pacer test, the capacitor loading became strange".The device only shocks 118 joules even when 200 joules were originally selected"."after restarting the device, the device was able to give off 200-joule shocks normally for the next 2-3 shocks, before the issue returned." it is to be assumed, but not as definitive root cause that the capacitor has had high leakage current since the device shocked normally again after the replacement of the capacitor.The case: (b)(4) is the first case with this issue, no others are known so far.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: 15484817
• MDR Text Key: 302960697
• Report Number: 3003832357-2022-00029
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-3020
• Device Catalogue Number: 453564842181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 09/01/2022
• Supplement Dates FDA Received: 09/07/2023
• 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