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

Model Number M5068A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It has been reported that the device is failing self-test.

Manufacturer Narrative

Correcting the become aware date only to november 19 2019 from january 19 2019.

• Brand Name: HEARTSTART HOME
• Type of Device: AED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021
• Manufacturer (Section G): PHILIPS HEALTHCARE - BOTHELL; 22100 bothell-everett hwy; bldg a; bothell WA 98021
• Manufacturer Contact: dana tackett ; 22100 bothell everett hwy; bothell, WA 98021
• MDR Report Key: 9355928
• MDR Text Key: 174746189
• Report Number: 3030677-2019-02324
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M5068A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0642-2013, Z-0643-2013
• Patient Sequence Number: 1