MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED PLUS; DEFIBRILLATOR

Model Number AED PLUS

Device Problem Failure of Device to Self-Test (2937)

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

Event Type  malfunction  

Event Description

Complainant alleged that during functional testing, the device prompted a "unit failed" message.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

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

• Brand Name: AED PLUS
• Type of Device: DEFIBRILLATOR
• 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: 19211878
• MDR Text Key: 341362997
• Report Number: 1220908-2024-01475
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 04560233596016
• UDI-Public: 04560233596016
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K011541/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2024

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: AED PLUS
• Device Catalogue Number: AED PLUS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2020
• 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