MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION R SERIES DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER

Model Number R SERIES

Device Problem Unintended Electrical Shock (4018)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event Description

Complainant alleged that while the user was performing a 30 joule test, when pressing the shock buttons on the paddles, the user received an unintended delivery of energy.Complainant did not indicate that there was any adverse effect to the user due to the reported malfunction.

Manufacturer Narrative

The device, paddles, and multifunction cable were returned to zoll medical corporation.The customer's report was not replicated or confirmed.The device passed visual inspection, shock testing, and electrical safety testing without duplicating the report.Review of the device logs found no errors or any indication of a device malfunction.There are no recorded patient shocks during the reported event dates and all 30 joule self tests are within acceptable ranges.The device was recertified and returned to the customer.It is important to note that the r series operators guide warns users on hand placement during a self test: "when performing this check, use your thumbs to operate the shock buttons in order to avoid inadvertent shock.No portion of the hand should be near the paddle electrode plates." analysis of reports of this type has not identified an increase in trend.

• Brand Name: R SERIES DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 12484672
• MDR Text Key: 271797442
• Report Number: 1220908-2021-02971
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946017279
• UDI-Public: 00847946017279
• Combination Product (y/n): N
• PMA/PMN Number: K060559/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other