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

Model Number 00-3020

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2022

Event Type  malfunction  

Manufacturer Narrative

The device was sent to schiller for investigation.Schiller informed that the device was received without the original battery hence they were not able to check if the failure to recognize the battery is reproducible.Schiller repair department checked the device with their own batteries and there was no problem.The reported problem was not confirmed.A review of the risk management file was performed, and the potential severity is s2 has been identified in the risk document.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 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.

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 that device failed to recognize the battery.The battery was full.Device tested with another battery and failed but the device passed manual self test.

• 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 ; altgasse 68; baar 6341 ; SZ 6341 ; 0417664242
• MDR Report Key: 17850653
• MDR Text Key: 324673155
• Report Number: 3003832357-2023-00679
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial

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: Other
• Device Model Number: 00-3020
• Device Catalogue Number: 989706001681
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 10/02/2023
• 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