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

Model Number 00-3020

Device Problem Unable to Obtain Readings (1516)

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

Event Date 04/24/2023

Event Type  Injury  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

It was reported the device would not capture any rhythm.The device displayed "check defibrillator electrodes".The user tried multiple pad sets and powering unit off/on with same results.The device was reported to be in use, however, no direct adverse event to the patient or user was reported.

Manufacturer Narrative

This issue was initially reported as a product problem.The customer provided additional information which clarified the users were attempting to deliver life-saving therapy to a critically ill patient but was unable due to the device not working as intended - ekg not capturing rhythm.Multiple attempts were made to obtain additional clinical and patient information to confirm the severity of the reported event and confirm patient outcome.However, these attempts were unsuccessful.In the absence of this information, this event will be considered an adverse event because live-saving therapy/treatment has been interrupted and or delayed.Although no direct adverse event to the patient or user was reported, we are considering this to be a serious injury due to a serious deterioration in the state of health of the patient because life-saving therapy/treatment may have been interrupted/delayed.

Event Description

Philips received a complaint on the tempus pro indicating that the tempus ls would not capture any rhythm.Ls displayed "check defibrillator electrodes".Crews tried multiple pad sets and powering unit off/on with same results.Three sets of pads (the same lot number) attempted across two tempus ls devices.Connection was checked.The users were attempting to deliver life-saving therapy to a critically ill patient but was unable due to the device not working as intended - ekg not capturing rhythm.Multiple attempts were made to obtain additional clinical and patient information to confirm the severity of the reported event and confirm patient outcome.However, these attempts were unsuccessful.In the absence of this information, this event will be considered an adverse event because live-saving therapy/treatment has been interrupted and or delayed.Although no direct adverse event to the patient or user was reported, we are considering this to be a serious injury due to a serious deterioration in the state of health of the patient because life-saving therapy/treatment may have been interrupted/delayed.

Manufacturer Narrative

This report is based on information provided by philips repair service personnel and has been investigated by the philips complaint handling team.The complaint was escalated for technical investigation and the results indicate that no errors were detected during the investigation of the device.Device worked as intended.Rescue file of 22-apr-2023 indicate that defib pads were recognized, but impedance measured around 17o which is lower than 25 o resulting in the fact that the defib pads were not recognized.Tempus ls displayed "check defibrillator electrodes".This msg is reported when the impedance range falls outside the acceptable range per the manual(25o-250o).The customer was provided a replacement device to resolve the issue.It has been concluded that no further action is required at this time.

• 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 ; 0417664242
• MDR Report Key: 16989585
• MDR Text Key: 315827613
• Report Number: 3003832357-2023-00330
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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?: 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?: Yes
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 04/24/2023; Not provided
• Supplement Dates FDA Received: 09/30/2023; 12/30/2023
• 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