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

Model Number 00-3020

Device Problem Failure to Shut Off (2939)

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

Event Date 09/22/2022

Event Type  malfunction  

Event Description

Philips received a complaint on the tempus ls indicating that device froze during the removal of the cpr meter, required battery removal to power down and reboot.The complaint was escalated for technical investigation by the original equipment manufacturer, schiller.The only log file that ends unexpectedly is 2022-09-22t20.42.43-04.00.Log.In all other files, a normal shutdown is seen.The user pressed shutdown after it went into transmission mode to transfer the data to the pro.After 10% of transmission progress there is no more data in the log file.So this could be where it crashed.There is no indication that it happened after removal of life point.There is no need to remove the battery.A power off long press so that the device is powered off by hardware would be the appropriate way.No tempus pro was available during the investigation and the event could not be reproduced.Based on the information available and the testing conducted, the cause of the reported problem was observed in the log file but unable to be reproduced.The reported problem was confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.A review of the risk management file was performed.While no harm was alleged, recurrence of this failure mode during clinical use could cause or contribute to death or serious injury.Therefore, this failure mode meets the definition of a reportable malfunction.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 sent a replacement device to address the issue.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

Updated conclusion code to cause not established.

• 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: 17867449
• MDR Text Key: 324873889
• Report Number: 3003832357-2023-00689
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• 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: 09/23/2022
• 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