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

Model Number 9355-0961-01

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Death (1802); Laceration(s) (1946)

Event Date 03/21/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

Complainant alleged that while performing cpr on a (b)(6) female patient, the patient received lacerations from the cpr puck.Complainant indicated that new pads were applied and chest compressions were maintained.However, cpr was unsuccessful and the patient expired.

Manufacturer Narrative

Corrective data sections: adverse event problem (patient code).The electrode pads were discarded and not available for evaluation.However, the data file was provided for review.The data file indicates that the defibrillator and electrode pads performed to specification.Cpr has known risks including chest trauma, broken ribs, or collapsed lungs.There is no information suggesting the device malfunctioned.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, ONESTEP CPR AA
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 8488244
• MDR Text Key: 141083593
• Report Number: 1218058-2019-00035
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 9355-0961-01
• Device Catalogue Number: 9355-0961-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 70 YR