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

Model Number 00-3020

Device Problem No Pacing (3268)

Patient Problem Unspecified Heart Problem (4454)

Event Date 08/26/2022

Event Type  Injury  

Event Description

It has been reported to philips that tempus ls failed to pace with defibrillator pacing module.A replacement device was sent to the customer.Log files and rescue files were received at schiller the manufacturer for a technical investigation.The device was returned to rdt.Based on the information available and the testing conducted, the cause of the reported problem was a communication error from the main board to the dpm module, error 26 was observed on the logfile.The reported problem was confirmed.Based on the information available, no further action is necessary at this time.Although no harm was reported by the user, given the reported clinical scenario, the reported device event will be considered an adverse event because live-saving therapy/treatment was not available, interrupted, or delayed and may have led to a deterioration in the state of the health of the patient.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.A replacement device was provided.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 17683196
• MDR Text Key: 322637221
• Report Number: 3003832357-2023-00582
• Device Sequence Number: 1
• Product Code: LDD
• 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
• Report Date: 09/05/2023

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?: Yes
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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