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

Model Number	X SERIES
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2018
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 while attempting to pace a (b)(6) year old male patient, the device failed to capture the patient's heart rhythm.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the device performed to specification.The device was recertified and returned to the customer.Review of the clinical data showed that the device did capture during the pacing period of the case.Prior to the pacing period the patient's heart rate is about 60 bpm.During the pacing period, the patient's heart rate stays at about 80 bpm and there is a qrs complex that follows the pacing spike.Once the pacing period was ended, the patient's heart rate returns back to about 60 bpm.Although it may be normal for muscle contractions during pacing, at the device setting used at the time of this reported event, muscle contraction should not be used as an indication of capture.The ecg signal on the device display is a more accurate indication of capture than muscle contraction.The data evidence supports that this report was unsubstantiated.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: 7738664
• Report Number: 1220908-2018-02166
• Device Sequence Number: 19161386
• Product Code: MKJ
• UDI-Device Identifier: 00847946018184
• UDI-Public: 00847946018184
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K112432/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): 07/11/2018

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: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR