MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY,MAIH, 3.0 DIA, W/SWITCH, 100-120VONLY, PACKAG; INTERNAL PADDLE

Model Number	1011-0139-04
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
Event or Problem Description
Complainant alleged that during functional testing, the associated device failed to discharge using these internal handles.Complainant did not indicate that there was any patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The internal handles will not be returned to zoll medical corporation.The biomed reported to zoll medical corporation that an internal inspection found a cut in the cable insulation showing internal wiring.Due to the age of these internal handles (47 months), they have most likely met their useful life and exceeded the maximum of 50 autoclave/sterilization cycles.The customer will remove this set of internal handles from service and will order a replacement set.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ASSY,MAIH, 3.0 DIA, W/SWITCH, 100-120VONLY, PACKAG
• 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: 15501442
• Report Number: 1220908-2022-03681
• Device Sequence Number: 7838612
• Product Code: LDD
• UDI-Device Identifier: 00847946022358
• UDI-Public: 00847946022358
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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: 1011-0139-04
• Device Catalogue Number: 8011-0139-04
• Was Device Available for Evaluation?: No
• 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: 09/07/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• 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: Unknown