HEARTSTART ONSITE M5066A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-05 for HEARTSTART ONSITE M5066A manufactured by Philips Medical Systems.

Event Text Entries

[126221181]
Patient Sequence No: 1, Text Type: N, H10

[126221182] It has been reported that the device is failing self-test.
Patient Sequence No: 1, Text Type: D, B5

[137110168] This case was previously reported on pr 8780453 with mdr #3030677-2018-02661. The investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 3030677-2018-02479
• MDR Report Key: 8038848
• Date Received: 2018-11-05
• Date of Report: 2018-10-10
• Date Mfgr Received: 2018-10-10
• Device Manufacturer Date: 2018-03-01
• Date Added to Maude: 2018-11-05
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MISS SHANNON DECKER
• Manufacturer Street: 22100 BOTHELL-EVERETT HWY BLDG A
• Manufacturer City: BOTHELL WA 980218431
• Manufacturer Country: US
• Manufacturer Postal: 980218431
• Manufacturer Phone: 8887445477
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 0

• Brand Name: HEARTSTART ONSITE
• Generic Name: AED
• Product Code: MLN
• Date Received: 2018-11-05
• Model Number: M5066A
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: PHILIPS MEDICAL SYSTEMS
• Manufacturer Address: 22100 BOTHELL EVERETT HWY BOTHELL WA 980218431 US 980218431

Device Sequence Number: 1

• Brand Name: HEARTSTART ONSITE
• Generic Name: AED
• Product Code: MLN
• Date Received: 2018-11-05
• Model Number: M5066A
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• 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		2018-11-05