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

Model Number 00-3020

Device Problems Circuit Failure (1089); Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191); No Pacing (3268)

Patient Problems Dyspnea (1816); Unspecified Heart Problem (4454); Insufficient Information (4580)

Event Date 06/29/2021

Event Type  Death  

Manufacturer Narrative

A user report was received related to a reported patient death which is currently being investigated.At the time of reporting, the device has not yet been returned for investigation.Further updates will be provided when the device is received and investigation has progressed.

Event Description

The incident described as follows by the customer - patient was (b)(6) female (dob: (b)(6)) with complaint of sob.Ekg: wide complex junctional rhythm.During transport paramedic attempted to pace patient and received the error message - check electrodes.Ems not able to access the pacing feature on tempus ls.It was reported the patient outcome was patient died.After arriving back at station personnel compared the action of the defib to another known good tempus ls and the two units did not work the same.Pacing feature was no able to be accessed on reported device.Electrode pads were placed on ems personnel and they continued to receive "check electrodes" error message.

Event Description

The incident described as follows by the customer - patient was 74 yo female (dob: (b)(6) 1946) with complaint of sob.Ekg: wide complex junctional rhythm.During transport paramedic attempted to pace patient and received the error message - check electrodes.Ems not able to access the pacing feature on tempus ls.It was reported the patient outcome was patient died.After arriving back at station personnel compared the action of the defib to another known good tempus ls and the two units did not work the same.Pacing feature was no able to be accessed on reported device.Electrode pads were placed on ems personnel and they continued to receive "check electrodes" error message.

Manufacturer Narrative

The customer was to return the tempus ls manual failure device.The tracking number (b)(4) given by customer is invalid and customer said that she can¿t provide any further information.Philips engineer called ups they have no record of a pick-up from that location from 7-28-21 to 8-20-21.Further checked with philips warehouse in mechanicsburg, pa where the device (sn: (b)(6)) was to be sent and device not received until 11 nov 2021.

Event Description

The incident described as follows by the customer - patient was 74 yo female (dob: (b)(6) 1946) with complaint of sob.Ekg: wide complex junctional rhythm.During transport paramedic attempted to pace patient and received the error message - check electrodes.Ems not able to access the pacing feature on tempus ls.It was reported the patient outcome was patient died.After arriving back at station personnel compared the action of the defib to another known good tempus ls and the two units did not work the same.Pacing feature was no able to be accessed on reported device.Electrode pads were placed on ems personnel and they continued to receive "check electrodes" error message.The device has been received and sent to manufacturer for investigation.It was found that the internal cable connecting the ecg connector to the print was not in the correct position.Based on the traces, it must be assumed that this cable was mounted correctly.The cable has come loose due to twisting of the ecg connector.Such an error should be noticed during the daily function test.According to log files the daily function tests were not done as required by the to ifu.

Manufacturer Narrative

Updated contact information , problem code , evaluation result code , component coded and conclusion code.

• 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: 12234522
• MDR Text Key: 263796857
• Report Number: 3003832357-2021-10001
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00-3020
• Device Catalogue Number: 989706001681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/30/2021
• Date Manufacturer Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Female