MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY, MAIH, 3.0 DIA, 7 FT, W/SWITCH, 100-240V, PAC; INTERNAL PADDLE

Model Number 1011-0141-04

Device Problem Failure to Deliver Shock/Stimulation (1133)

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

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 male patient (age unknown), these attached internal handles failed to discharge.Complainant indicated that the clinician obtained another device 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 zoll medical corporation; the customer's report was verified.The internal paddles failed to discharge during functional testing due to the shock button being stuck.Due to the age of the internal handles (30+ months) they most likely have met their useful life and exceeded the maximum of autoclave /sterilization cycles.The internal handles were scrapped and replacements were sent to the customer.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: ASSY, MAIH, 3.0 DIA, 7 FT, W/SWITCH, 100-240V, PAC
• Type of Device: INTERNAL PADDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 12296370
• MDR Text Key: 265669168
• Report Number: 1220908-2021-02588
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 00847946022891
• UDI-Public: 00847946022891
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

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: 1011-0141-04
• Device Catalogue Number: 1011-0141-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 07/27/2021
• Supplement Dates FDA Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2019
• 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 Sex: Male