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
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 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.
Additional 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
• Common Device Name: 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
• Report Number: 1220908-2021-02588
• Device Sequence Number: 16946451
• Product Code: LDD
• UDI-Device Identifier: 00847946022891
• UDI-Public: 00847946022891
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male