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

Model Number 00-3020

Device Problems Use of Incorrect Control/Treatment Settings (1126); No Pacing (3268)

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

Event Date 09/06/2022

Event Type  Injury  

Event Description

As described by the customer 'dpm hardware failure inop'.Device log files have been sent to the manufacturer schiller for an evaluation and as per that it could be the user changed to sync mode and did not press and hold the button as described within the ifu.A user report was received related to a reported product problem which is currently 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 investigation has progressed.

Manufacturer Narrative

Device log and rescue files were sent to the manufacturer schiller for evaluation.Based on the investigation of the log file, this error is caused due to communication error from the main board to the defibrillation-pacing module.However, the actual root cause cannot be concluded at this stage.The root cause shall be determined after the device was investigated at schiller.The report is attached to the complaint.The follow-up report will be submitted if any additional information is received.

Event Description

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 dsm hardware failure inop.

• 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: rekha rv ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 15484821
• MDR Text Key: 303630452
• Report Number: 3003832357-2022-00030
• 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?: 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
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 02/09/2023
• 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
• Patient Sex: Male