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

Model Number AED PLUS

Device Problems Unable to Obtain Readings (1516); Failure to Analyze Signal (1539)

Patient Problem Necrosis (1971)

Event Date 12/09/2023

Event Type  Death  

Manufacturer Narrative

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

Event Description

Complainant alleged that while attempting to treat a 68-year-old male patient, the device was unable to detect the attached pads.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section b5 and h6 (medical device problem code).Evaluation: the customer was contacted for return of the suspect product.The customer has responded and indicated the product will not be returning to zoll.

Event Description

Complainant alleged that while attempting to treat a 68-year-old male patient, the device was unable to analyze.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.

• 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: 18425503
• MDR Text Key: 331766867
• Report Number: 1220908-2023-05023
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946002152
• UDI-Public: 00847946002152
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011541/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: AED PLUS
• Device Catalogue Number: AED PLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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 Outcome(s): Death
• Patient Age: 68 YR
• Patient Sex: Male