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

Model Number 00-3020

Device Problem Unable to Obtain Readings (1516)

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

Event Type  malfunction  

Event Description

It has been reported to philips the ls, on cardiac arrest, would not trace ekg.Showing red line with tick marks at a rate close to 400.Green line remained flat.

Manufacturer Narrative

The assigned field service engineer (fse) confirmed, the issue.The log files were sent to schiller for investigation.On the date reported as to when the malfunction occurred, ((b)(6) 2023).Only self test was observed, in the log files and that the device was used in manual mode and not used on the patient.The log-files only show activity in manual mode.Pacemaker markers, red lines are only shown on a ecg.And only in pacer or monitor mode.The described issue seems to be happened in pacer or monitor mode.The described issue, red markers coming from a detected pacemaker are only displayed in pacer or monitor mode.All log-files do not show, that the device was ever run in another mode than manual.So therefore, it is not possible to give any conclusion for the described issue.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: jon yard ; altgasse 68; baar 6341 ; SZ 6341 ; 0417664242
• MDR Report Key: 17131091
• MDR Text Key: 317784143
• Report Number: 3003832357-2023-00376
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 07613365002737
• UDI-Public: 7613365002737
• 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: Health Professional
• 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: 06/14/2023
• 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: 453564842181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2023
• 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