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

Model Number 00-3020

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191); No Pacing (3268)

Patient Problems Unspecified Heart Problem (4454); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2022

Event Type  malfunction  

Event Description

Customer reports that 'unable to pace patient with this unit.Completed therapy with another tempus ls.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

It has been reported to philips that patient presented to ems providers to be in complete 3rd degree heart block with a rate of 20-30 bpm.

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 device failed to pace.Customer completed therapy with another tempus ls.This caused the delay in the treatment of about 15 min.The complaint was escalated for technical investigation.The logs and the device requested by rdt for investigation.Device received and the error 26 was observed.Considering all investigation results, schiller ag the manufacturer 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, schiller ag cannot come to a conclusion.Device transferred to loaner pool and it needs dpm upgrade.The customer was given the replacement device.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: 14697837
• MDR Text Key: 302601711
• Report Number: 3003832357-2022-00007
• 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

• Date FDA Received: 06/15/2022
• 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
• Date Manufacturer Received: 05/18/2022
• 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