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

Model Number 1011-0139-05

Device Problem Failure to Charge (1085)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 during biomed testing, the associated defibrillator was unable to charge using these attached internal handles.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The internal handles will not be returned to zoll medical corporation.The customer reported to zoll medical corporation that these internal handles were manufactured in 2014 and have gone through over 100 sterilization cycles.Due to the age of these internal handles (8 years), they have most likely met their useful life and have exceeded the maximum of 50 autoclave/sterilization cycles.The customer will remove this set of internal handles from service and will order a replacement set.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
• 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: 15496834
• MDR Text Key: 300714866
• Report Number: 1220908-2022-03655
• Device Sequence Number: 1
• Product Code: LDD
• 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: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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