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

Model Number 00-3020

Device Problem Unable to Obtain Readings (1516)

Patient Problems Unspecified Heart Problem (4454); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It has been reported to philips that during cardiac, (b)(6) attempted to attach the cardiac defibrillator pads to the shock box.When no rhythm was showing, ems attempted to flip the cord around and replug it in.No rhythm was being displayed.Ems attempted to place on the three lead ekg wires onto the pt to see if a rhythm would then display, and no rhythm would display.(b)(6) asked for assistance in troubleshooting.With shock box (333) attached the display shows no rhythm and advised "check pads." monitor 8 showed asystole with 4-lead.Pads were reconnected with no changes in error.Hard reboot was attempted, no changes.Pads were replaced, no changes.Kyle grabbed the monitor (9) (2510) and shock box off m473 and had similar issues initially, but he was able to troubleshoot and correct the issue.(2510) and shock box 9 had to be used throughout the remainder of the call.This did happen during patient care and could have negatively affected patient outcome.

• 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: 18867186
• MDR Text Key: 337234040
• Report Number: 3003832357-2024-00206
• 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: 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: 03/08/2024
• Is this an Adverse Event Report?: Yes
• 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: 03/06/2024
• 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): Life Threatening