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

Model Number 00-3020

Device Problem Battery Problem (2885)

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

Event Date 05/05/2022

Event Type  malfunction  

Event Description

It was reported to philips that during the endurance test, a warning that the battery could not be charged due to high temperature.The device was inspection was performed and report provided by schiller repair department confirmed that the speaker itself is functioning normally.There is an issue noticed on the device.During the endurance test, a warning that the battery could not be charged due to high temperature appeared.The repair department were working on what the underlying cause of this is.The warning that appeared stated that the battery could not be charged because the battery temperature was too high.It is unknown if the battery was exposed to high temperatures already when they conducted those tests and charged the battery in the process.Despite several days of reproduction attempts and high rate of defibrillation and pacing, they were not able to get it to again.R&d confirmed that continuous pacing and defibrillation should not be able to trigger a battery temperature too high warning.Device added to the loaner pool for upgrade.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 investigation concludes that no further action is required at this time.

• 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: jon yard ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 17413009
• MDR Text Key: 320241749
• Report Number: 3003832357-2023-00494
• Device Sequence Number: 1
• Product Code: LDD
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 00-3020
• Device Catalogue Number: 989706001681
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/05/2022
• 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): Other