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

Model Number	AED PLUS
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device issued a "shock advised" prompt for a heart rhythm they believed was non-shockable.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device was not returned to zoll medical (b)(4) for evaluation.After further customer contact, it was stated that "there was no fault with the device and it was a user error, cpr was being performed when patient was breathing".The customer also stated that the device will not be returned to zoll for evaluation.The device's indications for use instructs users to apply product to patient's who are pulseless or has no other signs of circulation.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: AED PLUS
• Common Device Name: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 8011430
• Report Number: 1220908-2018-03133
• Device Sequence Number: 1262334
• Product Code: MKJ
• UDI-Device Identifier: 00847946002381
• UDI-Public: 00847946002381
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K011541/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: 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 Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 10/28/2018
• Supplement Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1