MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FR3, REFURB TEXT AED, LANGUAGE CONFIGURA

Model Number 861388

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem No Patient Involvement (2645)

Event Date 05/12/2020

Event Type  Death  

Manufacturer Narrative

New information received 08jun2020 indicates the patient did not survive.

Event Description

During a patient use event, the user states there was no sound from the device.The patient did not survive.

Event Description

During a patient use event, the user states there was no sound from the device.There was no patient incident.

• Brand Name: FR3, REFURB TEXT AED, LANGUAGE CONFIGURA
• 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: 10132720
• MDR Text Key: 194931083
• Report Number: 3030677-2020-00913
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 861388
• Device Catalogue Number: 861388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2011
• 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
• Patient Outcome(s): Death