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

Model Number R SERIES

Device Problems Self-Activation or Keying (1557); Unintended Electrical Shock (4018)

Patient Problems Cardiac Arrest (1762); Insufficient Information (4580)

Event Date 06/29/2023

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 male patient (age unknown), the device self discharged while the nurse was performing cpr, the nurse received an unintended delivery of energy.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient and indicated that the attending nurse was inspected by a doctor and was cleared.

Manufacturer Narrative

Zoll medical corporation evaluated the device and the device performed to specification.The device was put through extensive testing including electrical safety testing, impedance and defibrillation cycle testing without duplicating a malfunction.The device was recertified and returned to the customer.Review of the device activity logs showed the device discharged due to a registered shock button press while an operator was in contact with the patient.The r series operator's guide states for all personnel to stand clear of the patient prior to defibrillation discharge.The text from the operator's guide says, "warning! warn all persons in attendance of the patient to stand clear prior to defibrillator discharge.Do not touch the bed, patient, or any equipment connected to the patient during defibrillation.A severe shock can result.Do not allow exposed portions of the patient's body to come into contact with metal objects, such as a 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
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 17568213
• MDR Text Key: 321381939
• Report Number: 1220908-2023-03203
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946017521
• UDI-Public: 00847946017521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2023

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: 08/03/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 07/28/2023
• Supplement Dates FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male