HEARTSTART FR3 989803149941

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-25 for HEARTSTART FR3 989803149941 manufactured by Philips Medical Systems.

Event Text Entries

[26953186]
Patient Sequence No: 1, Text Type: N, H10

[26953187] The user is questioning the functionality of the qcpr meter during a patient use event. Patient outcome is unknown.
Patient Sequence No: 1, Text Type: D, B5

[34777743] (b)(4). Please note - this report is regarding a qcpr meter and not the actual aed device.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 3030677-2015-02297
• MDR Report Key: 5106145
• Date Received: 2015-09-25
• Date of Report: 2015-09-09
• Date Mfgr Received: 2015-09-08
• Device Manufacturer Date: 2013-09-01
• Date Added to Maude: 2015-09-25
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: EMERGENCY MEDICAL TECHNICIAN
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS. DANA TACKETT
• Manufacturer Street: 22100 BOTHELL EVERETT HWY
• Manufacturer City: BOTHELL WA 980218431
• Manufacturer Country: US
• Manufacturer Postal: 980218431
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HEARTSTART FR3
• Generic Name: CPR METER
• Product Code: LIX
• Date Received: 2015-09-25
• Model Number: 989803149941
• Lot Number: 8011313746
• ID Number: N/A
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PHILIPS MEDICAL SYSTEMS
• Manufacturer Address: 22100 BOTHELL EVERETT HWY BOTHELL WA 980218431 US 980218431

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-09-25