MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONE STEP PEDIATRIC CPR ELECTRODE (1 PAIR); AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	8900-000219-01
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the associated device was unable to obtain an ecg signal via these attached electrode pads.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The complainant was contacted for return of the electrode pads.The lot number of the pads is unknown, no retained sample testing can be performed.The pads have not been returned to zoll for evaluation.

• Brand Name: ONE STEP PEDIATRIC CPR ELECTRODE (1 PAIR)
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• 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: 16125807
• Report Number: 1218058-2022-00171
• Device Sequence Number: 6547635
• Product Code: MKJ
• UDI-Device Identifier: 00847946023348
• UDI-Public: 00847946023348
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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
• Operator of Device: Other
• Device Model Number: 8900-000219-01
• Device Catalogue Number: 8900-000219-01
• 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: 12/19/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown