MAUDE Adverse Event Report: BIO-DETEK INCORPORATED STAT PADZ, W/PRECONNECT, ADLT-12, MULTI-LANGUAGE; ELECTRODE

Model Number 8900-4003-49

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), after removing the electrode pads, burns of an unknown degree were found on the patient's skin.Please reference medwatch report 1218058-2023-00180 for a similar event reported from the same customer.

Manufacturer Narrative

The stat padz were returned to zoll medical corporation for evaluation.However, the pads returned were not applied to a patient or used in a clinical event.The returned pads were determined to have strong adhesion and were assembled according to specification.An ecg signal was acquired using the returned stat padz and energy was delivered successfully.The log was not available to review for the reported event date.The stat padz were scrapped after testing.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: STAT PADZ, W/PRECONNECT, ADLT-12, MULTI-LANGUAGE
• 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: 18336171
• MDR Text Key: 330610224
• Report Number: 1218058-2023-00181
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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: Other
• Device Model Number: 8900-4003-49
• Device Catalogue Number: 8900-4003-49
• Device Lot Number: 3423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2023
• 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 Outcome(s): Other