MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES (MSERIES)

Model Number 8011-0501-01

Device Problem Failure to Deliver Shock/Stimulation (1133)

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

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the associated defibrillator failed to discharge using these attached internal handles.Complainant indicated that the clinician obtained another set of internal handles to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The internal handles were returned to a zoll approved service provider for evaluation.The customer's report was not replicated or confirmed.The internal handles were applied to a test device and were put through extensive testing including the ohms measurement test and the discharge test without duplicating the report.A replacement set of internal handles were shipped to the customer.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: AUTOCLAVABLE INTERNAL HANDLES (MSERIES)
• Type of Device: INTERNAL HANDLE
• 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: 17919255
• MDR Text Key: 325479019
• Report Number: 1220908-2023-03965
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K963781
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8011-0501-01
• Device Catalogue Number: 8011050101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2021
• 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