MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTREAM FR2; AED

Model Number M3841A

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem Atrial Fibrillation (1729)

Event Type  malfunction  

Event Description

During a patient use event, the customer is stating the defibrillator did not recommend a shock when the patient was in fibrillation.The patient survived.

Manufacturer Narrative

(b)(4).

• Brand Name: HEARTSTREAM FR2
• Type of Device: AED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021 8431
• 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 98021-8431
• MDR Report Key: 5581533
• MDR Text Key: 43335625
• Report Number: 3030677-2016-00923
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: 003565
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3841A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2009
• 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