MAUDE Adverse Event Report: BIO-DETEK INCORPORATED DURA-PADZ GEL (12/CASE); ELECTRODE

Model Number	8900-0325
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 during functional testing, the associated device failed self test with the attached electrode pads.Complainant did not indicate that there was any patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.The reported malfunction was duplicated and attributed to the electrode crp-d padz sensor/puck.The pads were tested with a test device and it prompted a unit failed message.However, the "unit failed" message occurred in non-rescue mode, which indicates that the device would still function in rescue or clinical mode.Review of device's history logs indicates that there was a communication issue (non critical error) between the device and the cpr puck.Which confirms that the device was capable of delivering therapy in rescue or clinical mode.Reports of this nature are typically not considered to have any clinical impact.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: DURA-PADZ GEL (12/CASE)
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 8621248
• Report Number: 1218058-2019-00044
• Device Sequence Number: 2172984
• Product Code: MKJ
• UDI-Device Identifier: 10847946016293
• UDI-Public: 10847946016293
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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: 09/24/2020
• Device Model Number: 8900-0325
• Device Catalogue Number: 8900-0325
• Device Lot Number: 3918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1