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

Model Number	R SERIES
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the device performed to specification.The device was recertified and returned to the customer.Review of the device activity logs showed that the device was in aed mode.The device performed an analysis and advised a shock be delivered.The shock button was registered as being pressed and energy was delivered.After the shock button was pressed the first time, the shock button was pressed again and then the device was switched off.The device was powered up again in aed mode and the shock button was pressed in rapid succession.The device did not deliver a shock because the device had not completed the analysis period.The log shows a check pads message occurred, which means the device could not measure a valid patient impedance.The user must exit aed mode in order to manually use the r series.The rseries charge button, by design, does not function while in aed mode.During the analysis phase, the device will charge on it's own but will not discharge unless the end user pressed the shock button.In aed mode, the device will perform an analysis every 2 minutes, or it can be manually prompted by the user from the number 6 softkey on the front panel of the device.There was no evidence found in the log review that the analyze key was depressed by the user at any time.This report has been closed as device meets specification as the device would not shock in aed mode unless the analysis has been successfully performed.No trend associated with complaints of this nature.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device failed to charge.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

• Brand Name: R SERIES DEFIBRILLATOR
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 9571868
• Report Number: 1220908-2019-04149
• Device Sequence Number: 13560085
• Product Code: MKJ
• UDI-Device Identifier: 00847946002343
• UDI-Public: 00847946002343
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K060559/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1