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

Model Number M3841A

Device Problem Invalid Sensing (2293)

Patient Problem Death (1802)

Event Type  Death  

Event Description

During a pt use event, the user is questioning the analysis process of the device.Pt did not survive.

Manufacturer Narrative

(b)(4).Device evaluation pending.

• Brand Name: HEARTSTREAM FR2
• Type of Device: AED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021 843
• Manufacturer Contact: shannon decker ; 22100 bothell everett hwy; bothell, WA 98021-8431
• MDR Report Key: 4723267
• MDR Text Key: 5738845
• Report Number: 3030677-2015-00994
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 003565
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Emergency Medical Technician
• Type of Report: Initial
• Report Date: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M3841A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2010
• 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