MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY, MAIH, 2.0 DIA, W/SWITCH, 100-120VONLY; INTERNAL HANDLE (STEM)

Model Number	1011-0139-05
Medical Device Problem Code	Failure to Convert Rhythm (1540)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2019
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 defibrillate a (b)(6) male patient, during aortic valve replacement surgery, the device failed to cardiovert the patient's rhythm using external paddles.Complainant indicated that the clinician attached electrode pads to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Evaluation: the internal handles were received at zoll medical corporation for review and the customer's report was not replicated or confirmed.The internal handles were subjected to multiple discharge testing, cable stress testing and continuity testing without duplicating the report.Visual inspection of the internal handles yielded no discrepancies.Patient motion does not explicitly indicate energy delivery, and the device log would contain energy delivery and impedance information.The device activity logs from the event were not returned as part of this investigation.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a (b)(6) year-old-male patient, during aortic valve replacement surgery, there was no patient movement during discharge.Complainant indicated that the clinician attached electrode pads to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

• Brand Name: ASSY, MAIH, 2.0 DIA, W/SWITCH, 100-120VONLY
• Common Device Name: INTERNAL HANDLE (STEM)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 8861582
• Report Number: 1220908-2019-02137
• Device Sequence Number: 3447608
• Product Code: LDD
• UDI-Device Identifier: 00847946023010
• UDI-Public: 00847946023010
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K972241
• 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): 07/15/2019

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: 1011-0139-05
• Device Catalogue Number: 8011-0139-05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR