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

Model Number 00-3020

Device Problems Circuit Failure (1089); Intermittent Continuity (1121)

Patient Problem Insufficient Information (4580)

Event Date 10/11/2021

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) old male (dob: (b)(6)) with possible complaints of sids (sudden infant death syndrome).Pedi pads were placed on the patient.Patient was in asystole.¿mid arrest lost ecg signal unplugged and plug in pads for 25-30 sec and then started working¿ patient transported to hospital where he was pronounced dead.

Event Description

The incident described as follows by the customer - patient was 2 months old male (dob: (b)(6) 2021) with possible complaints of sids (sudden infant death syndrome).Pedi pads were placed on the patient.Patient was in asystole.¿mid arrest lost ecg signal unplugged and plug in pads for 25-30 sec and then started working¿ patient transported to hospital where he was pronounced dead.The device investigated by the manufacturer schiller.No device failure was detected during the entry test.The device passed all tests successfully.Based on the rescue files, it can be shown that at no time of the intervention any ecg signal was recorded.As the customer claims that an "ecg signal" was recorded but disappeared intermittently, the customer must have meant the defi signal recorded via the defib pads.The recordings of the defi signal shows several disconnections (the first disconnection of the signal was recorded after ca.25 minutes of cpr on the patient which was already in asystole up on arrival).Several disconnections were recorded after defibrillator pads were connected to the tempus ls manual.The defibrillator pads were then placed on a person.The device was started and an ecg signal was visible.It was not possible to reproduce the described issue, despite all the effort.Therefore, it can be concluded, that the device worked as intended according to it's specification and any incompatibility between the tempus ls manual and the defibrillator pads can be excluded.

• 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: selvaganesan balu ; ascent 1, aerospace centre; aerospace boulevard; farnborough ; UK
• MDR Report Key: 12917335
• MDR Text Key: 281603456
• Report Number: 3003832357-2021-10004
• 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

• 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
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2020
• 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
• Patient Age: 2 MO
• Patient Sex: Male