MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PEDI PADZ SOLID GEL RADIOLUCENT PEDIATRIC MULTI-FU; ELECTRODE

Model Number	8900-1007-01
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while performing open heart surgery on a (b)(6)-year-old patient (gender unknown), the device displayed a "check pads" message.Complainant indicated that the clinician obtained another set of pads to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The actual electrode pads were not returned to zoll medical corporation for evaluation.Instead, a lot number of the pads was provided.An investigation was conducted on retained samples lot 3820 for the customer's report.The retained samples were subjected to full electrical testing, continuity and shock testing, and adhesive testing with passing results.Based on the evaluation of the retained samples it was concluded that the samples were assembled according to specification.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: PEDI PADZ SOLID GEL RADIOLUCENT PEDIATRIC MULTI-FU
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 11456002
• Report Number: 1218058-2021-00030
• Device Sequence Number: 3523910
• Product Code: MKJ
• UDI-Device Identifier: 00847946016357
• UDI-Public: 00847946016357
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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 Expiration Date: 09/17/2021
• Device Model Number: 8900-1007-01
• Device Catalogue Number: 8900-1007-01
• Device Lot Number: 3820
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 YR