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

Model Number 00-3020

Device Problems Failure to Deliver Shock/Stimulation (1133); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Cardiac Arrest (1762)

Event Date 03/31/2023

Event Type  Injury  

Event Description

It was reported to philips that tempus ls-manual did not function as expected during a patient use event.

Manufacturer Narrative

This report is based on information provided by a philips field service engineer and schiller (equipment manufacturer) and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus ls manual indicating that the device energy selection would not increase above 100 joules.While the device was noted to be in use, there was reportedly no patient or user harm or impact however failure to shock/pace is considered a serious injury due to a serious deterioration of health that may result from a delay or failure to shock/pace.A replacement device was sent to the customer.The log and rescue files and the device were received at schiller where a technical investigation was completed.On the date of the event, 31mar2023 no intervention was observed however on the 21mar2023 the log file showed that the energy was kept to 100 joules when the 'energy up' button was pressed.This was because the energy electrode type was changed to paediatric mode before attempting to increase the energy, in paediatric mode the energy is limited to 100 joules.The technical investigation root cause was concluded to be user error.The returned device was removed from service and processed following local procedures.Based on the information available and the testing conducted, the cause of the reported problem was user error.To date there is no patient information in regards to the age of the patient so although error had occurred the exact error is not known i.E.Choosing the wrong mode or misunderstanding the energy output for each mode.The reported problem was confirmed (in paediatric mode the device will not increase above 100 joules).Based on the information available, no further action is necessary at this time.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.A replacement device was provided.Analysis was performed and investigation has been completed.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: 16811178
• MDR Text Key: 313962628
• Report Number: 3003832357-2023-00241
• 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: 04/25/2023
• 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: 453564842181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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; Life Threatening