MAUDE Adverse Event Report: SCHILLER AG TEMPUS LS-MANUAL ADULT ELECTRODES

Model Number	01-3020
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that potentially 220 pads were experiencing faulty adhesive, where the adhesive was sticking to the protective paper instead of the pads.Complaint database limitations prevent more than a quantity of (b)(4 from being added at this time.Please consider the quantity to be(b)(4) as reported by the customer.

• Brand Name: TEMPUS LS-MANUAL ADULT ELECTRODES
• Common Device Name: TEMPUS LS-MANUAL ADULT ELECTRODES
• Manufacturer (Section D): SCHILLER AG; altgasse 68; baar 6341 ; SZ 6341
• Manufacturer (Section G): SCHILLER AG; altgasse 68; baar 6341 ; SZ 6341
• Manufacturer Contact: mark o'dwyer ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 19214282
• Report Number: 3003832357-2024-00350
• Device Sequence Number: 8198320
• Product Code: LDD
• UDI-Device Identifier: 05060472441959
• UDI-Public: 05060472441959
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K200849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: 01-3020
• Device Catalogue Number: 989706010040
• Device Lot Number: MULTIPLE
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 07/11/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown