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

Model Number 00-3020

Device Problem No Pacing (3268)

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

Event Date 01/31/2024

Event Type  malfunction  

Event Description

It has been reported to philips during acls training and practice, a crew member attempted to start the pacemaker function and received a warning that read "dpm failure".During an acls class last month, we had another unit show the same error, we thought maybe it was an issue with our rhythm generator but the problem did not persist when using a third ls unit most recently.No patient involvement.

• Brand Name: TEMPUS LS
• 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: 18640459
• MDR Text Key: 334546734
• Report Number: 3003832357-2024-00091
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• 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
• Date Manufacturer Received: 01/31/2024
• 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