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 Deliver Shock/Stimulation (1133)

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

Event Date 08/07/2023

Event Type  malfunction  

Event Description

Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the associated defibrillator failed to discharge using these internal paddles.Complainant indicated that the clinician obtained another set of internal paddles to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

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

Manufacturer Narrative

The internal handles were returned to zoll medical corporation for evaluation.The customer's report was verified and attributed to faulty switch wire on the internal handles.The internal handles were scrapped after evaluation.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: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 17819452
• MDR Text Key: 324287199
• Report Number: 1220908-2023-03634
• 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: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• 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-XX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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