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

Model Number	AED PLUS
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Death (1802)
Date of Event	10/16/2019
Type of Reportable Event	Death
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 failed to discharge.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
The ecg data from the event was returned and evaluated.Evaluation found that only one analysis event was performed.During the entire 9 second analysis segment, the patient was presenting asystole which is not a shockable rhythm.The analysis results returned was no shock advised.Based on our review of the data we have concluded that the analysis program results were correct for the specific analysis in question and that there was no indication of a malfunction with the device 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: 9247637
• Report Number: 1220908-2019-03454
• Device Sequence Number: 19765841
• Product Code: MKJ
• UDI-Device Identifier: 00847946002183
• UDI-Public: 00847946002183
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K011541/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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
• 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: 10/16/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death