MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY,MAIH,2.0 DIA, W/SWITCH, 100-120VONLY, PACKAG; INTERNAL PADDLE

Model Number	1011-0139-05
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 (b)(6) year old male patient, 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.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section d4 (serial #).Evaluation: the internal handles were returned to zoll medical corporation.The customer's report was duplicated and attributed to the shock button being stuck.However, the handles do not have the ability to be disassembled and reassembled.X-ray images were taken and visual evaluation of the images are unable to identify any manufacturing related issues.Investigation attributed the issue to a faulty switch.The internal handles were scrapped.A replacement was sent to the customer.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ASSY,MAIH,2.0 DIA, W/SWITCH, 100-120VONLY, PACKAG
• Common Device Name: INTERNAL PADDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 11889077
• Report Number: 1220908-2021-01698
• Device Sequence Number: 14380038
• Product Code: LDD
• UDI-Device Identifier: 00847946022365
• UDI-Public: 00847946022365
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/07/2021

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: 1011-0139-05
• Device Catalogue Number: 8011-0139-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR