MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO PADZ, MFE, RADIOLUCENT, ADULT, HVP; DEFIB/PACING ELECTRODE

Model Number 8900-4005

Device Problem Unable to Obtain Readings (1516)

Patient Problem Subcutaneous Nodule (4548)

Event Type  malfunction  

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), the associated device displayed a "poor pad contact" message using these electrode pads.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.Please reference medwatch reports 1218058-2023-00030, 1218058-2023-00031, 1218058-2023-00032, 1218058-2023-00034, 1218058-2023-00035, 1218058-2023-00036, 1218058-2023-00038, 1218058-2023-00039, and 1218058-2023-00040 for similar events reported from the same customer.

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Manufacturer Narrative

The actual electrodes from the event were disposed of at the customer site and are not available for evaluation.No clinical log files were provided by the customer for review and the patient's skin condition is unknown.Therefore, electrodes from retained samples of the same lot number 4722 were investigated.The retained samples were subjected to extensive testing including a review of the device history record, as well as a 24-hour wear test with no loss of adherence or ecg signal observed.It was concluded that the retained electrodes were assembled according to specification.No trend is associated with reports of this type.

• Brand Name: PRO PADZ, MFE, RADIOLUCENT, ADULT, HVP
• Type of Device: DEFIB/PACING ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 16481013
• MDR Text Key: 310725995
• Report Number: 1218058-2023-00033
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

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: Other
• Device Expiration Date: 11/19/2023
• Device Model Number: 8900-4005
• Device Catalogue Number: 8900-4005
• Device Lot Number: 4722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 02/10/2023
• Supplement Dates FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2022
• 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