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

Model Number 00-3020

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 12/13/2022

Event Type  Injury  

Event Description

Philips received a complaint on the tempus ls indicating pads connection issue.It was reported that during treatment, event pro data shows repeated rapid "connect, disconnect, connect, disconnect" of pads without the pads ever being removed from the patient." the device had been received by the manufacturer schiller for investigation, while the customer was given loaner.The investigation performed by schiller based on the provided information and data, showed that the frequency of the disconnections seem to correlate with the frequency of cpr performed.As these disconnections were detected by the device, schiller may conclude that the device worked as intended and did not cause the disconnections.It is most likely that the disconnections are caused by incorrect placement of the electrodes.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

Correction to is: the device was returned to rdt and the customer received the replacement.The logs were send to schiler for investigation.Schiller observed the connection issue during the medical intervention occurred on the (b)(6) 2022.- based on the logs, on the (b)(6) 2022 only a self-test occurred.Schiller suspect that the correct date of the incident was on the (b)(6) 2022.Between the blue brackets, multiple instances of electrode connection/disconnection events observed.Log files on the device dating to the (b)(6) 2022 also show the connection/disconnection of the defibrillator (pad) electrodes being disconnected/reconnected.The log messages show that cpr was performed.Schiller explained that it is reasonable to assume that the electrodes were not placed correctly and that interruptions occurred due to the cpr.The interruptions also seem to correlate with the cpr frequency.Schiller informed that none of the rescue files provided match the date that the incident reportedly occurred, (b)(6) 2022.Rdt team contacted the customer to get the confirmation of the incident occurrence.The customer corrected the date to (b)(6) 2022.Three recordings in sema were looked at.The first two had no sign of electrode disconnection.Then on the third, there is 1 disconnection recorded at 22:54:05 that persists until the end of the recording.This contradicts the statement "shows repeated rapid "connect, disconnect, connect, disconnect¿.The log messages listed show that cpr was performed.It is therefore reasonable to assume that the electrode was not stuck properly and that interruptions occurred due to the cpr.The interruptions also seem to correlate with the cpr frequency.Therefore, and since the disconnection was detected by the device, sag may conclude that the device was working as intended and the disconnection was caused by improperly applied electrodes.Rdt investigation: analyzed log and rescue files of date (b)(6) 2022, the logs indicate that several pads attachments & detachments were detected.Looking at impedance value measured by the pads, impedance value begins at 182ohm then rises to 250ohm over course of time then fluctuates around upper limit of 250ohm, hence several pads attachments & detachments detected by user.Also logs indicate cpr was performed during this time causing fluctuation in impedance value.Tempus ls displays "check defibrillator electrodes" also meaning pads not recognized.This msg is reported when the impedance range falls outside the acceptable range per the user manual(25 o-250 o).When the impedance measurement is out of range (less than 25o and or greater than 250o), tempus ls does not display the ecg signals.While no harm was alleged, recurrence of this failure mode during clinical use could cause or contribute to death or serious injury.Therefore, this failure mode meets the definition of a reportable malfunction.Appropriate regulatory reporting actions have been taken.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

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 pads connection issue.It was reported that during treatment, event pro data shows repeated rapid "connect, disconnect, connect, disconnect" of pads without the pads ever being removed from the patient." the device was returned to rdt and the customer received the replacement.The logs were send to schiler for investigation.Schiller observed the connection issue during the medical intervention occurred on the (b)(6) 2022.- based on the logs, on the (b)(6) 2022 only a self-test occurred.Schiller suspect that the correct date of the incident was on the (b)(6) 2022.Between the blue brackets, multiple instances of electrode connection/disconnection events observed.Log files on the device dating to the (b)(6) 2022 also show the connection/disconnection of the defibrillator (pad) electrodes being disconnected/reconnected.The log messages show that cpr was performed.Schiller explained that it is reasonable to assume that the electrodes were not placed correctly and that interruptions occurred due to the cpr.The interruptions also seem to correlate with the cpr frequency.Schiller informed that none of the rescue files provided match the date that the incident reportedly occurred, (b)(6) 2022.Rdt team contacted the customer to get the confirmation of the incident occurrence.The customer corrected the date to (b)(6) 2022.Three recordings in sema were looked at.The first two had no sign of electrode disconnection.Then on the third, there is 1 disconnection recorded at 22:54:05 that persists until the end of the recording.This contradicts the statement "shows repeated rapid "connect, disconnect, connect, disconnect¿.The log messages listed show that cpr was performed.It is therefore reasonable to assume that the electrode was not stuck properly and that interruptions occurred due to the cpr.The interruptions also seem to correlate with the cpr frequency.Therefore, and since the disconnection was detected by the device, sag may conclude that the device was working as intended and the disconnection was caused by improperly applied electrodes.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 17743575
• MDR Text Key: 323375034
• Report Number: 3003832357-2023-00595
• Device Sequence Number: 1
• Product Code: LDD
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 11/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other