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

Model Number	X SERIES
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 during functional testing, the device was unable to obtain an ecg signal via multifunction cable.Complainant did not indicate that there was any patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device was not returned.Instead, the multifunction cable was returned.The customer's report was not replicated or confirmed.The multifunction cable was put through extensive testing, full functionality testing with a test x-series and simulator, multiple discharges and analysis, and visual inspection, and full functionality testing by manufacturing without duplicating the malfunction.The multifunction cable was scrapped as a precaution.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: 9457575
• Report Number: 1220908-2019-03851
• Device Sequence Number: 11532644
• Product Code: DRT
• UDI-Device Identifier: 00847946016807
• UDI-Public: 00847946016807
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K112432/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

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: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1