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

Model Number M5066A

Device Problems Nonstandard Device (1420); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The device was returned without an allegation from the customer, and an issue was found in the data log.

• 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: 11346804
• MDR Text Key: 233759048
• Report Number: 3030677-2021-00501
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: 020715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M5066A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• 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