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

Model Number 1011-0139-05

Device Problem Failure to Convert Rhythm (1540)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event 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.

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 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
• Type of Device: INTERNAL HANDLE (STEM)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 8861582
• MDR Text Key: 153599414
• Report Number: 1220908-2019-02137
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 00847946023010
• UDI-Public: 00847946023010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972241
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Model Number: 1011-0139-05
• Device Catalogue Number: 8011-0139-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR