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

Model Number 00-3020

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Unspecified Heart Problem (4454)

Event Date 03/06/2023

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 patient did not receive shock when synchronized cardioversion was attempted.The crew attempted synchronized cardioversion on patient but were unsuccessful.The patient did not receive a shock.The crew attempted a second time and was successful.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

Additional remote diagnostic technologies investigation: the log and rescue files were analyzed for event date (03-mar-2023), few connections/disconnections of pads were observed, the impedance measured by pads was stable (within acceptable range) throughout the event except for those connections and disconnects by user.The device was charged once, shock delivered once which is probably what customer claims as 2nd attempt to shock the patient.The logs do not have any other signs of attempts made on charging or shocking which the customer claims as patient did not receive shock in 1st attempt.It can be assumed as user error.

Manufacturer Narrative

This report is based on information provided by philips remote service engineer and schiller investigation team and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus ls indicating the patient did not receive shock when synchro cardioversion was attempted.Crew attempted synchro cardioversion on patient but were unsuccessful.Patient did not receive a shock.Crew attempted a second time and was successful.It is alleged, that monitor did not cardiovert.Remote support was provided and recorded that the crew claims that monitor did not cardiovert when attempting.It is unclear as the monitor was only charged 1 time and successfully defibrillated at that time.There was some intermittent pad tracing problems in the case, but they do not appear to line up with the reported error.Device arrived at schiller.Incoming tests were carried out and no errors detected.Pacing was run several times at 180/min, 200ma and no errors were observed.On the activity recorded 3.03.3023 there were a few electrodes connected and disconnected.The capacitor was only charged once.A successful sync shock was delivered.There is no evidence of (unsuccessful) first shock attempt.There is only one successful sync shock.It was concluded that the device worked as intended.The reported problem was not confirmed.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-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: tanya deschmidt ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 16613162
• MDR Text Key: 311974669
• Report Number: 3003832357-2023-00149
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• 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
• Date Manufacturer Received: 03/06/2023
• 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
• Patient Age: 54 YR
• Patient Sex: Male