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

Model Number R SERIES

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 04/18/2023

Event Type  Injury  

Event Description

Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), a staff member received an unintended delivery of energy.Complainant did not indicate that there was any adverse effect to the staff member due to the reported malfunction.

Manufacturer Narrative

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

Manufacturer Narrative

Zoll medical canada evaluated the device and the device performed to specification.The device was put through extensive testing including functional and electrical safety testing without duplicating the report.The device was recertified and returned to the customer.Review of the log on showed on (b)(6) 2023 the device is used to shock 8 times.All recorded measured patient impedances and delivered energy are within expectation.It is not likely that the operator received energy from the device.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." r series devices are to be used by trained personnel.Additionally, the user must always press the shock button to deliver the energy.The r series is not designed and is not capable of delivering energy on it's on while in either mode (aed or manual).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: 16878412
• MDR Text Key: 314661743
• Report Number: 1220908-2023-01782
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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