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

Model Number R SERIES

Device Problem Premature Activation (1484)

Patient Problem Shock (2072)

Event Date 04/06/2021

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 attempting to treat a patient (age & gender unknown), the device inappropriately self-discharged and delivered a shock to the patient and the attending nurse received an unintended delivery of enegry.Complainant did not indicate that there was any adverse effect to patient or to the nurse due to the reported malfunction.

Manufacturer Narrative

The device was returned to zoll medical corporation.The customer's report was unsubstantiated.Review of the device log shows evidence that the device was manually charged and shocked by manual button presses.It was confirmed by the customer that the nurse touched the patient when the shock occurred.The device was recertified and returned to the customer.The r series operator's guide warns that all persons in attendance of the patient are to "stand clear" prior to defibrillator discharge.It also indicates do not touch the bed, the patient, or any of the equipment connected to the patient during defibrillation of energy.A severe shock can result.Additionally, users should not allow exposed portions of the patient's body to come into contact with metal objects, such as bed frame, as unwanted pathways for defibrillation current may result.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: 11734796
• MDR Text Key: 247782487
• Report Number: 1220908-2021-01284
• Device Sequence Number: 1
• Product Code: MKJ
• 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: 04/06/2021

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: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other