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

Model Number 00-3020

Device Problems Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/08/2022

Event Type  Death  

Event Description

As described by the customer 'unit failed to display during patient care'.During evaluation stage, customer confirmed death of patient.Unit would not display ecg waveforms during patient monitoring.Philips rdt planning to receive the device for the investigation".

Manufacturer Narrative

Philips received a complaint on the tempus ls indicating that device was not displaying ecg waveforms, in pads mode during a patient care event.The technical investigation of the log file analysis concluded that the device did not show any abnormalities or even a malfunction.The reported problem was not confirmed.A review of the risk management file was performed.This complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

Updated evaluation method code grid originally provided on mfr# 3003832357-2022-00026.

• 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: tanya deschmidt ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 15361032
• MDR Text Key: 299273514
• Report Number: 3003832357-2022-00026
• 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

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: 453564842181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 08/08/2022; 12/04/2023
• Supplement Dates FDA Received: 08/24/2023; 02/06/2024
• 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): Death