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

Model Number 00-3020

Device Problem Failure to Run on Battery (1466)

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

Event Date 07/15/2022

Event Type  malfunction  

Manufacturer Narrative

The device was replaced for the customer.The alleged `faulty` device requested and received at the bench.The fault was not reproducible during the incoming inspection.However the log files could not be retrieved.The root cause to the original complaint can not be determined.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 customer was provided a replacement device to resolve the issue.The alleged `faulty` device was returned from schiller and sent to loaner pool.It has been concluded 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 exhibited the error message "battery not recognized".The battery was tried in a different unit with no messages displayed.As well as the battery from a different unit installed in this unit showing the same message.No damage observed to either the battery or the battery space in the ls.

• 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: 17860369
• MDR Text Key: 324792018
• Report Number: 3003832357-2023-00685
• 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?: Yes
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 10/03/2023
• 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