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

Model Number 00-3020

Device Problems Appropriate Term/Code Not Available (3191); No Pacing (3268)

Patient Problems Cardiac Arrest (1762); Insufficient Information (4580)

Event Date 04/14/2022

Event Type  Injury  

Event Description

As described by customer "i had a crew attempting to take a transcutaneous pacing patient and they attached the equipment to the patient and when they tried to apply power through the ls, they received the code ¿hardware fault dpm¿.The call is complicated by the fact that the hospital staff detached their 3 lead ecg cables on their monitor as soon as our crew arrived, and their pacer began asynchronous pacing instead of demand, so there were shocks being given that weren¿t necessary.The crew received the same fault message when they tried to pace a second time without the hospital equipment attached.They called for a second ambulance and switched ls units and continued the call that way.The ls unit is passing the self test, and it also behaves exactly as i would expect now that i am testing it with a rhythm generator.From the manufacturer investigation based on the provided logfile and information, the pacer stopped due to the error 26.However, the trigger and actual root cause of the error 26 cannot be concluded at this stage.It is not sure whether the error was caused due to use error or a device error.

Manufacturer Narrative

It has been reported philips that the type of reported complaint is serious injury and product problem code is updated.

Manufacturer Narrative

This report is based on information provided by schiller repair service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating that tempus ls failed to pace patient.Crew attempted to take a transcutaneous pacing patient and they attached the equipment to the patient and when they tried to apply power through the ls, they received the code ¿hardware fault dpm¿.The call is complicated by the fact that the hospital staff detached their 3 lead ecg cables on their monitor as soon as our crew arrived, and their pacer began asynchronous pacing instead of demand, so there were shocks being given that weren¿t necessary.The crew received the same fault message when they tried to pace a second time without the hospital equipment attached.They called for a second ambulance and switched ls units and continued the call.The ls unit passed the self test, and it passed test with a rhythm generator.The investigation of this issue was performed based on the provided information and logfile.The investigation of the logfile showed that the issue is caused by an error 26.The same issue was not found to be appearing before and after the complained date of occurrence.This complained issue appears to be a non-reporoducible pacer error, which is logged as error 26 in the logfile.As the error is not reproducible, the root cause can't be concluded.However, it is suspected that the error is caused due to communication issue to the dpm board.This error is under observation in sagqi-137 - tempus ls: pacer issues.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.The investigation concludes that no further action is required at this time.

• 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 ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 14728621
• MDR Text Key: 301991937
• Report Number: 3003832357-2022-00008
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2022

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?: No
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 06/17/2022
• Supplement Dates Manufacturer Received: 04/14/2022; 04/14/2022
• Supplement Dates FDA Received: 03/28/2023; 07/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2021
• 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