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

Model Number	1011-0139-05
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/17/2015
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 open chest defibrillation on a (b)(6) old male patient in ventricular fibrillation, the associated defibrillator displayed a "paddle error" message using these internal handles.Complainant indicated that the patient was placed on bypass and converted to an organized rhythm spontaneously.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the internal handles and the reported malfunction was not replicated or confirmed.The internal handles were put through extensive testing without duplicating the malfunction.Replacement internal handles were sent to the customer.No trend is associated with reports of this type.

• Brand Name: ASSY,MAIH,2.0 DIA, W/SWITCH, 100-120VONLY, PACKAGE
• Common Device Name: INTERNAL PADDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 6855326
• Report Number: 1220908-2017-02151
• Device Sequence Number: 16346302
• Product Code: LDD
• UDI-Device Identifier: 00847946022365
• UDI-Public: 00847946022365
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2017

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: 09/18/2017
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR