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

Model Number 00-3020

Device Problems Appropriate Term/Code Not Available (3191); Incomplete or Inadequate Connection (4037)

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

Event Date 05/11/2022

Event Type  malfunction  

Event Description

As described by the customer 'does not recognize defib pads when attached.Check electrodes message'.The patient pads were being used on a cardiac arrest patient.These pads had been opened prior to the call and had been kept in their opened package.They had not been used or removed from the package; the package was just opened for ease of access.When these pads were placed on the patient the tempus ls did not recognize that the pads had been connected to the monitor.My crew thought that it was a problem with the pad and retrieved an unopened set from the medic unit.These pads also were not recognized by the monitor.When i returned to the office on the following day the shift supervisor and myself opened a set of unissued pads from our supply room and attempted to see if these would connect and be recognized by the monitor.They were not recognized by the ls that we sent in but were recognized by a second ls that we used to help identify the problem.The pads were placed on me and were recognized on the second ls but not the ¿broken¿ ls.Nothing was attached to the pads themselves other than their normal packaging.They were plugged into the ls.The current sets i have are pn 01-3020.From the manufacturer initial evaluation- based on the provided information by the customer, a use error can most likely be ruled out, as the customer swapped out the defib pads immediately when they realized this issue.Furthermore, the customer also stated that this issue was reproducible after the intervention and they ruled out that the pads were faulty by applying the same pads to a second device on which they were able to record an ecg signal.

Manufacturer Narrative

Customer was asked to provide the rescue files by the schiller manufacturer.Investigation was not able to proceed as requested file was unavailable until (2022-06-22).The requested files have not been provided to schiller ag.Therefore no investigation could be performed.However, based on the provided information by the customer, a use error can most likely be ruled out, as the customer swapped out the defi pads immediately when they realized this issue.Furthermore, the customer also stated that this issue was reproducible after the intervention, and they ruled out that the pads were faulty by applying the same pads to a second device on which they were able to record an ecg signal.The investigations involved a "good faith effort" to obtain information and the device for the investigation.Despite all the efforts, schiller was not able to obtain the requested information and device.Therefore, no investigation could be done.

Event Description

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 that the device does not recognize defib pads when attached and getting a check electrodes message.

• 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: rekha rv ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 15025494
• MDR Text Key: 303632570
• Report Number: 3003832357-2022-00017
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: No
• 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