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

Model Number	R SERIES
Medical Device Problem Codes	Self-Activation or Keying (1557); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device self-discharged and a clinician and a crna both received an unintended delivery of energy.Complainant indicated that there was no adverse effect to the patient, the clinician proceeded to the emergency department, was deemed ok and it was not known if there was any adverse effect to the crna due to the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation and there was no indication of a device malfunction.The device passed all testing, was recertified, and returned to the customer.Review of the device log shows evidence that the device did not discharge on its own and was a result of a button press.The r series operator's guide states to 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 in contact with metal objects, such as a bed frame, as unwanted pathways for defibrillation current may result.All information suggests that the device operated as intended.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: R SERIES DEFIBRILLATOR
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 12725427
• Report Number: 1220908-2021-03749
• Device Sequence Number: 3983728
• Product Code: MKJ
• UDI-Device Identifier: 00847946002336
• UDI-Public: 00847946002336
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K060559/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2021

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
• Operator of Device: Other
• Device Model Number: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2021
• Supplement Date Received by Manufacturer: 10/09/2021
• Initial Report FDA Received Date: 10/30/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown