AED PLUS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-27 for AED PLUS manufactured by Zoll Medical Corporation.

Event Text Entries

[51157259] The device was returned to zoll medical corporation; the malfunction was duplicated and attributed to a faulty resistor on the main board. Analysis for reports of this type has not identified an increase in trend.
Patient Sequence No: 1, Text Type: N, H10

[51157260] Complainant alleged that during functional testing, the device prompted a "unit failed" message. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1220908-2016-01742
• MDR Report Key: 5826017
• Date Received: 2016-07-27
• Date of Report: 2016-07-07
• Date Mfgr Received: 2016-07-07
• Device Manufacturer Date: 2016-02-01
• Date Added to Maude: 2016-07-27
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 269 MILL ROAD
• Manufacturer City: CHELMSFORD MA 01824
• Manufacturer Country: US
• Manufacturer Postal: 01824
• Manufacturer Phone: 9784219552
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: AED PLUS
• Generic Name: DEFIBRILLATOR
• Product Code: MJK
• Date Received: 2016-07-27
• Returned To Mfg: 2016-07-18
• Model Number: AED PLUS
• Catalog Number: AED PLUS
• Lot Number: NA
• ID Number: 00847946002152
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZOLL MEDICAL CORPORATION
• Manufacturer Address: 269 MILL ROAD CHELMSFORD MA 01824 US 01824

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-07-27