EASY PULSE 5 198705

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-10-17 for EASY PULSE 5 198705 manufactured by Precision Medical, Inc..

Event Text Entries

[5146824] Pt was using oxygen conserver for therapy, device did not deliver oxygen causing the pt to have a noxic event leading to her death.
Patient Sequence No: 1, Text Type: D, B5

[12210472] This was unk complaint, never reported to us, the serial number and name of device was made known to precision medical on (b)(4) 2014.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2523148-2014-00004
• MDR Report Key: 4197469
• Report Source: 00
• Date Received: 2014-10-17
• Date of Report: 2014-10-17
• Date of Event: 2014-01-13
• Date Mfgr Received: 2014-09-19
• Device Manufacturer Date: 2005-02-01
• Date Added to Maude: 2014-10-24
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: JIM PARKER
• Manufacturer Street: 300 HELD DR.
• Manufacturer City: NORTHAMPTON PA 18067
• Manufacturer Country: US
• Manufacturer Postal: 18067
• Manufacturer Phone: 6102626090
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EASY PULSE 5
• Generic Name: CONSERVER
• Product Code: NFB
• Date Received: 2014-10-17
• Model Number: 198705
• Catalog Number: 198705
• Lot Number: NA
• ID Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PRECISION MEDICAL, INC.
• Manufacturer Address: 300 HELD DR. NORTHAMPTON PA 18067 US 18067

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2014-10-17