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

Model Number	R SERIES
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device failed self test.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The reported malfunction was observed and attributed to a faulty test port.This is a malfunction which only impacts the self-test portion with the defibrillator.Once the multi-function connection is removed from the test port and attached to a set of electrode pads or external paddles the device performs to specification.This type of malfunction does not pose any clinical impact and does not meet our guidelines for reportability.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: 7532860
• Report Number: 1220908-2018-01392
• Device Sequence Number: 1652714
• Product Code: MKJ
• UDI-Device Identifier: 00847946002398
• UDI-Public: 00847946002398
• 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
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1