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

Model Number	X SERIES
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age and gender unkown), the device failed self-test for defib and pacer functions.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation; the reported malfunction was observed during testing.However, the reported problem could not be duplicated once the device was disassembled during trouble-shooting.The device was put through extensive testing without duplicating the reported malfunction.The device's processor/bridge/pace board was replaced as a precaution.The device was recertified and returned to the customer.No trend is associated with reports of this type.

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 6690249
• Report Number: 1220908-2017-01577
• Device Sequence Number: 1973237
• Product Code: MKJ
• UDI-Device Identifier: 00847946005849
• UDI-Public: 00847946005849
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2017

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: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Initial Date Received by Manufacturer: 06/16/2017
• Supplement Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1