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

Model Number AED PRO

Device Problem Failure to Power Up (1476)

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

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event Description

Complainant alleged that during functional testing, the device would not power up.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The device was returned to zoll medical corporation for evaluation.The customer's report was duplicated and attributed to a depleted battery.As a result, a new battery is recommended to resolve the report.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: AED PRO
• 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: 19211720
• MDR Text Key: 341359400
• Report Number: 1220908-2024-01463
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016128
• UDI-Public: 00847946016128
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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 PRO
• Device Catalogue Number: AED PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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