MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODE, ONESTEP CPR A/A GC

Model Number 9600-000251-06

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), the pads were damaged during opening/removal of packaging and they were unable to attach them to the patient.Complainant indicated that the clinician obtained another set of electrode pads to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The electrodes that were used during the event were not returned to zoll medical corporation for evaluation.However, the lot number 1919 was provided for retain sample testing.A visual inspection and electrical testing, including 30 joule self tests did not find any discrepancies.The customer's report was not duplicated and it was concluded that the retained pairs of electrodes were assembled according to specification.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODE, ONESTEP CPR A/A GC
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 9151735
• MDR Text Key: 177811791
• Report Number: 1218058-2019-00137
• 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
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/07/2021
• Device Model Number: 9600-000251-06
• Device Catalogue Number: 9600-000251-06
• Device Lot Number: 1919
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1