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 Problem Cardiac Arrest (1762)

Event Date 07/21/2023

Event Type  Injury  

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 attempting to defibrillate a patient (age & gender unknown), the device self discharged.Three of the team members reported feeling an `impulse` as a result of the defibrillator delivering a shock.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.Unknown if any adverse effect to the three team members.

Manufacturer Narrative

Zoll medical corporation evaluated the data file and the customer's report was not confirmed.Review of the activity log indicated the device is powered on, analyzed, and prompted shock advised.The device recorded the prompt "press shock" and "stand clear".The device also recorded a "fully release" prompt, indicating that the operator was in contact with the patient, performing cpr.A shock button press is then recorded followed by a discharge.The recorded impedance is expected for a patient with good coupling and does not include a spike that would indicate poor coupling or the added impedance of an operator.The log suggests that the device discharged as a result of a button press.The report of the operator's receiving a shock cannot be verified by the log.However, the log does suggest that cpr was being performed at the time of the shock advised.The r series is not designed to deliver energy on its own while in either mode (aed or manual).The shock button must be pressed to deliver the energy.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: 17809369
• MDR Text Key: 324160439
• Report Number: 1220908-2023-03836
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• 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
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2020
• 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