MAUDE Adverse Event Report: BIO-MED DEVICES BIO-MED; O2 AIR BLENDER

Model Number 2003

Device Problems Defective Device (2588); Device Operates Differently Than Expected (2913)

Patient Problems Complaint, Ill-Defined (2331); High Oxygen Saturation (2478)

Event Date 07/04/2014

Event Type  No Answer Provided  

Event Description

Oxygen blender was reading 80-90 percent too high.Blender was set at 26 percent - blender was delivering 80 percent o2.Pt was receiving higher level of oxygen that prescribed.Blender has been checked by the biomed company.The evaluation of the o2 blender completed by bio med - unit found defective and removed from operations.Unit to be refurbished and re-tested by hss.

Event Description

Add'l info receive from mfr on 11/11/2014: we are in receipt of med medwatch report #mw5037436 from cdrh.I just wanted to update fda that i am in limbo as to filing our own report because we are not getting any response from the user facility to our f/u inquiries.The user facility (b)(6) hospital (b)(6) never contacted as about this incident in the first place, all we know is what we read on the maude report fda routed to us.This report does not show any device serial number which i can find.I emailed the user facility ((b)(6) - the address provided on the fda maude report in hand) in (b)(6) and received no reply (and no failure to deliver messages).I phoned (b)(6) (at (b)(6) - the initial reporter id and phone number provided on the fda maude report in hand) in (b)(6) and have yet to receive a reply.I do know that previously in 2014 this facility had a problem with no emptying their water traps, which fouled another oxygen blender internally.

• Brand Name: BIO-MED
• Type of Device: O2 AIR BLENDER
• Manufacturer (Section D): BIO-MED DEVICES; guilbord 06437
• MDR Report Key: 3961124
• MDR Text Key: 4560933
• Report Number: MW5037436
• Device Sequence Number: 1
• Product Code: BZR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2003
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 60