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

Model Number 00-3020

Device Problems Appropriate Term/Code Not Available (3191); No Pacing (3268)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2022

Event Type  malfunction  

Event Description

As customer described - crews responded for a patient, during the care cycle pacing was indicated, pacing was then attempted with the device stopping and initiating a ¿dpm hardware failure¿ message.A second apparatus was called and a second ls was used to pace the patient to the hospital.Patient care was transferred to the hospital, the patient was alive and being treated by hospital staff.Some time after the hospital initiated patient transfer to a more advanced hospital, the customer was dispatched for this transport.During the second encounter with this patient, a second ls failed to pace with ¿ dpm hardware failure¿, another apparatus was called to provide pacing during transportation to the advanced hospital.The log files of the device were analysed by schiller (manufacturer).As per that the pacer started several times but always stopped.The "hardware failure (dpm)¿ was displayed to the user.This event seems to be a known issue "pacer error 26" which is non-reproducible and is under trending and internal investigation with the dedicated (b)(4) (capa-(b)(4)) - tempus ls: pacer issues.

Event Description

As customer described - crews responded for a patient, during the care cycle pacing was indicated, pacing was then attempted with the device stopping and initiating a ¿dpm hardware failure¿ message.A second apparatus was called and a second ls was used to pace the patient to the hospital.Patient care was transferred to the hospital, the patient was alive and being treated by hospital staff.Some time after the hospital initiated patient transfer to a more advanced hospital, the customer was dispatched for this transport.During the second encounter with this patient, a second ls failed to pace with ¿ dpm hardware failure¿, another apparatus was called to provide pacing during transportation to the advanced hospital.The log files of the device were analysed by schiller (manufacturer).As per that the pacer started several times but always stopped.The "hardware failure (dpm)¿ was displayed to the user.This event seems to be a known issue "pacer error 26" which is non-reproducible and is under trending and internal investigation with the dedicated sagqi-137 (capa-0029) - tempus ls: pacer issues.The device has been investigated by the manufacturer schiller and no problem was found with the device.A report from the manufacturer has been attached.

• Brand Name: TEMPUS LS - MANUAL
• Type of Device: LOW ENERGY DEFIBTRLLATOR
• 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: 14497787
• MDR Text Key: 300557430
• Report Number: 3003832357-2022-00005
• 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?: 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 02/07/2022
• 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): Other