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

Model Number 00-3020

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 01/21/2022

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 complaint as described by the customer "we ran a cardiac arrest this morning and got rosc.We attempted to pace due to rate.We remembered this time to put a 3 lead attached to the ls, switched it to fixed mode, then increased the rate to 70-80, then attempted to set current.However, it would not allow us to increase beyond 35 ma.We switched it to demand, yet it still did not work".

Event Description

The complaint as described by the customer "we ran a cardiac arrest this morning and got rosc.We attempted to pace due to rate.We remembered this time to put a 3 lead attached to the ls, switched it to fixed mode, then increased the rate to 70-80, then attempted to set current.However, it would not allow us to increase beyond 35 ma.We switched it to demand, yet it still did not work".The customer received replacement device.The failure device log files and rescue files have been sent to the manufacturer(schiller) for investigation.Investigation report is attached.The patient did not die during intervention, but 9 hrs later in icu.There is no information about the clinical status of the patient after being transferred to the icu in the morning.The analysis of the log files showed that the pacer had stopped because the impedance of the pads were too high.So there was no device hardware failure happened.The full disclosure report from the device is not available.The investigation is inconclusive as necessary information - full disclosure file could not be obtained by customer service department despite at least three (3) separate attempts.Based on the available information, the assumption is that the issue might be related to the pads.Nissha medical technologies - the legal manufacturer of the pads was informed by schiller about the latest complaints involving tempus ls pads.

• Brand Name: TEMPUS LS-MANUAL
• Type of Device: LOW ENERGY DEBFIBRILLATOR
• Manufacturer (Section D): SCHILLER AG; altgasse 68; baar 6341 ; SZ 6341
• Manufacturer (Section G): SCHILLER AG; altgasse 68; baar 6341 ; SZ 6341
• Manufacturer Contact: selvaganesan balu ; ascent 1, aerospace centre; aerospace boulevard; farnborough ; UK
• MDR Report Key: 13560111
• MDR Text Key: 285826162
• Report Number: 3003832357-2022-00002
• 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: 02/18/2022
• 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
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2020
• 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): Death