MAUDE Adverse Event Report: BIO-DETEK INCORPORATED STAT-PADZ II; DEFIB/PACING ELECTRODES

Model Number	8900-0801-01
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the pads were missing the films between the cardboard and the gel after opening/removal of packaging.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
The stat-padz ii were not returned to zoll medical corporation for evaluation.The customer provided photos showing the electrodes and the pouch, but with no styrene booklet.The pads appeared to be adhered to the cardboard inserts, covering the gel and surrounding the foam, which appears to be damaged/torn.The cardboard inserts are placed on the non-release side of the styrene, opposite to the pads.If the pads were applied to the non-release side of the styrene, they would adhere to cardboard and the edges of the styrene, damaging the surrounding foam upon removal.A review of the device history record for lot 1023 of the stat-padz ii electrodes showed no anomalies with the assembly and that the product was manufactured to specification.No similar events reported.No trend is associated with reports of this type.

• Brand Name: STAT-PADZ II
• Common Device Name: DEFIB/PACING ELECTRODES
• 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: 20858043
• Report Number: 1218058-2024-00113
• Device Sequence Number: 14418678
• Product Code: MKJ
• UDI-Device Identifier: 00847946016326
• UDI-Public: (01)00847946016326(17)250311(10)1023
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P160022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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
• Operator of Device: Other
• Device Expiration Date: 03/11/2025
• Device Model Number: 8900-0801-01
• Device Lot Number: 1023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ZOLL DEFIBRILLATION ELECTRODES 8900-0802-02
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown