MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART ONSITE; AED

Model Number M5066A

Device Problem Device Sensing Problem (2917)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The device did not recognize the pads during a patient use event.This could impact or potentially impact therapy while in use on a patient.Patient outcome is unknown.

• Brand Name: HEARTSTART ONSITE
• Type of Device: AED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021
• Manufacturer Contact: shannon decker ; 22100 bothell everett hwy; bothell, WA 98021
• MDR Report Key: 10892249
• MDR Text Key: 218931919
• Report Number: 3030677-2020-01916
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838075849
• UDI-Public: (01)00884838075849
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: 020715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M5066A
• Device Catalogue Number: 861282
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1