MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY,MAIH, 2.7 DIA, W/SWITCH, 100-120V ONLY; INTERNAL PADDLE

Model Number 1011-0139-03

Device Problem Failure to Discharge (1169)

Patient Problem No Information (3190)

Event Date 12/30/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that while attempting to treat a (b)(6) male patient, the associated defibrillator was unable to discharge using these internal handles.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The device was returned to zoll medical corporation; the malfunction was duplicated and attributed to a faulty pin.The handles were scrapped and the customer received a replacement.It's important to mention these handles are over a 11 years of age and are recommended to be replaced after either 100 sterrad or 50 autoclave cycles of sterilization.Zoll also recommends a functional inspection prior to each use.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: ASSY,MAIH, 2.7 DIA, W/SWITCH, 100-120V ONLY
• 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: 7228512
• MDR Text Key: 98583641
• Report Number: 1220908-2018-00214
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 00847946022341
• UDI-Public: 00847946022341
• 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: 01/10/2018

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
• Device Operator: Other
• Device Model Number: 1011-0139-03
• Device Catalogue Number: 8011-0139-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 01/30/2018
• Supplement Dates Manufacturer Received: 01/10/2018
• Supplement Dates FDA Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2006
• 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: 62 YR