MAUDE Adverse Event Report: BIO-DETEK INCORPORATED CPR-D PADZ ONE PIECE ELECTRODE PAD WITH REAL CPR

Model Number 8900-0800-01

Device Problem Patient Device Interaction Problem (4001)

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

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event Description

Complainant alleged that while attempting to monitor a 50-60-year-old female patient, the electrodes would not adhere to the patient's skin.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

• Brand Name: CPR-D PADZ ONE PIECE ELECTRODE PAD WITH REAL CPR
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: tina lombari ; 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 18949295
• MDR Text Key: 338567326
• Report Number: 1218058-2024-00022
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946000189
• UDI-Public: 00847946000189
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2024

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
• Device Operator: Health Professional
• Device Model Number: 8900-0800-01
• Device Catalogue Number: 8900-0800-01
• Device Lot Number: 3023B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female