MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION MAIN ASSEMBLY, BLS, ZOLL AED 3, ENGLISH AHA; DEFIBRILLATOR

Model Number 1128-001103-01

Device Problems Failure to Cycle (1142); Unable to Obtain Readings (1516)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Complainant alleged that during functional testing, the device inappropriately shuts off after partial boot cycle.Complainant did not indicate that there was any patient involvement in the reported malfunction.

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

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.Device evaluation: the device was returned to zoll medical corporation for evaluation.The customer's report was observed during review of the device data logs.The device was put through extensive testing including bench handling, impedance, and defibrillation cycle testing without duplicating the report.The device was recertified and returned to the customer.The pads used were not returned for evaluation.Analysis of reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that during functional testing, the device did not detect attached electrode pads.Complainant did not indicate that there was any patient involvement in the reported malfunction.

• Brand Name: MAIN ASSEMBLY, BLS, ZOLL AED 3, ENGLISH AHA
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 17660670
• MDR Text Key: 322372575
• Report Number: 1220908-2023-03404
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946020071
• UDI-Public: 00847946020071
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

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: 1128-001103-01
• Device Catalogue Number: 1128-001103-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 08/11/2023
• Supplement Dates FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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