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

Model Number 1011-0139-05

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 08/17/2015

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event 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.

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
• Type of Device: 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: 6855326
• MDR Text Key: 85652418
• Report Number: 1220908-2017-02151
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 00847946022365
• UDI-Public: 00847946022365
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 78 YR