MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, ONESTEP CPR, SINGLE

Model Number	9355-0953-01
Medical Device Problem Code	Unable to Obtain Readings (1516)
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 a routine shift check by a clinician, the associated device displayed a "poor pad contact" message using these electrodes.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The actual electrodes from the event were not available for evaluation.Instead, electrodes from retained samples of the same lot number were investigated.Evaluation of the electrodes did not reveal any irregularities that would have contributed to the reported event.Analysis of reports of this type has not identified an increase in trend.
Additional Manufacturer Narrative
The electrodes were returned for evaluation; the malfunction was duplicated during visual evaluation.The malfunction was attributed to a disconnected jumper wire (self test wire) on the electrode pad.This type of failure does not disable the electrode from delivering therapy when attached to a defibrillator.This is a malfunction which only impacts self-test of the electrode with the defibrillator.This type of malfunction does not pose any clinical impact and does not meet our guidelines for reportability.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, ONESTEP CPR, SINGLE
• Common Device Name: ELECTRODES
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 8817834
• Report Number: 1218058-2019-00089
• Device Sequence Number: 16731412
• Product Code: MKJ
• UDI-Device Identifier: 00847946016265
• UDI-Public: 00847946016265
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2019

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: 07/30/2019
• Device Model Number: 9355-0953-01
• Device Catalogue Number: 9355-0953-01
• Device Lot Number: 3117A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/02/2019; 07/02/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/30/2019; 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1