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 Consequences Or Impact To Patient (2199)
Date of Event	02/29/2020
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 monitor a patient (age & gender unknown), the device displayed an "ecg disabled" message.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.Please reference medwatch report number 1220908-2020-00678 for a similar report from the same customer.
Additional Manufacturer Narrative
The device was returned to zoll medical (b)(6) service department and the customer's report was observed during review of the device activity logs.The device was put through extensive testing including bench handling and full ecg functional stress testing without duplicating the report.A visual inspection of the multi-function receptacle did observe signs consistent with fretting and as a result, the defib cable receptacle was replaced as a precaution.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 9884262
• Report Number: 1220908-2020-00687
• Device Sequence Number: 2897319
• Product Code: MKJ
• UDI-Device Identifier: 00847946012649
• UDI-Public: 00847946012649
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112432/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

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: 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: 03/05/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1