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

Model Number M3841A

Device Problems No Audible Alarm (1019); Failure of Device to Self-Test (2937)

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 and there is no sound.

• Brand Name: HEARTSTREAM FR2
• Type of Device: AED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021 8431
• Manufacturer Contact: shannon decker ; 22100 bothell everett hwy; bothell, WA 98021-8431 ; 8887445477
• MDR Report Key: 6817499
• MDR Text Key: 83687331
• Report Number: 3030677-2017-01717
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: 003565
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3841A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 08/22/2017
• Supplement Dates FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2011
• 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