MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED3; DEFIBRILLATOR

Model Number	AED3
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device and battery were not returned to zoll medical corporation for evaluation.Instead, the data file was returned.Review of the device history log observed a"self test battery voltage was critically low" message.This message was preceded by a "battery below remaining capacity threshold" message.The corrective action for these messages would be battery replacement.The customer's report was observed in the data file.The battery will not be returned as part of this investigation.Analysis of reports of this type has not identified an increase in trend.
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 during incoming inspection, the device prompted a "unit failed" message.Complainant indicated that there was no patient involvement in the reported malfunction.

• Brand Name: AED3
• Common Device Name: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 8851481
• Report Number: 1220908-2019-02156
• Device Sequence Number: 13828970
• Product Code: MKJ
• UDI-Device Identifier: 00847946020941
• UDI-Public: 00847946020941
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P160022
• 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): 07/11/2019

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
• Operator of Device: Other
• Device Model Number: AED3
• Device Catalogue Number: AED3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1