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

Model Number 00-3020

Device Problems Loose or Intermittent Connection (1371); Unable to Obtain Readings (1516)

Patient Problems Unspecified Heart Problem (4454); Insufficient Information (4580)

Event Date 04/24/2023

Event Type  Injury  

Event Description

It has been reported to philips that the device would not capture the patient's rhythm due to the device not reading the pads.Pads were replaced and the issue remained.There is no known impact or consequence to the patient.

Event Description

Philips received a complaint on the tempus ls manual indicating that the device would not capture ecg (electrocardiogram) rhythm.While the device was noted to be in use, there was reportedly no patient or user harm or impact however, the inability to cardiovert the patient who is in a potentially lethal arrhythmia is a life-threatening situation and this complaint is considered a serious injury.

• 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 ; altgasse 68; baar 6341 ; SZ 6341 ; 0417664242
• MDR Report Key: 16910964
• MDR Text Key: 314995609
• Report Number: 3003832357-2023-00298
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 05/20/2024
• 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): Other