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

Model Number AED PLUS

Device Problem Failure to Analyze Signal (1539)

Patient Problem Loss of consciousness (2418)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that while analyzing the heart rhythm of a (b)(6)female patient who was unconscious and had labored breathing, the device returned a "shock advised" determination for what appeared to be a non-shockable heart rhythm.The clinician indicated that the patient had a pulse of 76.Complainant indicated that the clinician did not administer the shock to the patient.Complainant indicated that the patient was transported to a hospital and there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed.Review of device's clinical data does confirm the device prompted no shock advised.The customer report is not confirmed.As a post result of our investigation, zoll medical's ifu states: use the aed when a suspected cardiac arrest victim has an apparent lack of circulation indicated by: unconsciousness, absence of normal breathing, and absence of a pulse or signs of circulation.Therefore, the device should not have been applied to the patient.This claim is being closed as evidence supports report was unsubstantiated and the customer has been informed with the results of our findings.The device was recertified and returned to the customer.No trend is associated with reports of this type.

• Brand Name: AED PLUS
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 6400893
• MDR Text Key: 69861353
• Report Number: 1220908-2017-00504
• 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
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 03/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• 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 Age: 47 YR