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

Model Number 01-3020

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2022

Event Type  malfunction  

Event 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
• Type of Device: 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: tanya deschmidt ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 19214282
• MDR Text Key: 341710986
• Report Number: 3003832357-2024-00350
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 05060472441959
• UDI-Public: 05060472441959
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

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: 01-3020
• Device Catalogue Number: 989706010040
• Device Lot Number: MULTIPLE
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/30/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1