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

Model Number	R SERIES
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2020
Type of Reportable Event	Malfunction
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 treat a patient (age & gender unknown) the device issued a "shock advised" prompt for a heart rhythm they believed was non-shockable.Complainant indicated that the clinician disabled the energy and did not deliver the shock to the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device was not returned to zoll for evaluation.Review of the clinical data file provided determined that there was no clear indication that this patient was in a cardiac arrest at the time of the report.Follow up with the customer confirmed that the patient was awake and talking.The clinical review observed motion artifacts in the ecg during analysis causing the rhythm to appear chaotic and thus return a shockable determination.According to the r series operator's guide, when operating in aed mode, the patient must meet the following criteria: be unconscious, absence of breathing and absence of a pulse.In this case, with the patient awake and talking, the use of a 3 lead ecg cable would have been more appropriate.No device malfunction; the device was connected to a patient using a feature outside the intended use.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
• MDR Report Key: 9954726
• Report Number: 1220908-2020-01121
• Device Sequence Number: 10935174
• Product Code: MKJ
• UDI-Device Identifier: 00847946017286
• UDI-Public: 00847946017286
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 03/23/2020

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: Other
• Device Model Number: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1