MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY, MAIH, 2.0 DIA, 7 FT, W/SWITCH, 100-240V, PAC; INTERNAL HANDLE

Model Number	1011-0141-05-08
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that during biomed testing, the associated device failed self test using these internal handles.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The internal handles were returned to zoll medical germany for evaluation.The customer's report was observed an attributed to the returned internal handles.The internal handle set was scrapped at zoll germany to resolve the report.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ASSY, MAIH, 2.0 DIA, 7 FT, W/SWITCH, 100-240V, PAC
• Common Device Name: INTERNAL HANDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 13208313
• Report Number: 1220908-2021-04661
• Device Sequence Number: 2187383
• Product Code: LDD
• UDI-Device Identifier: 00847946022976
• UDI-Public: 00847946022976
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/20/2021

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: 1011-0141-05-08
• Device Catalogue Number: 1011-0141-05-08
• 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: 12/20/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 02/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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