MAUDE Adverse Event Report: BIO-MED DEVICES, INC. BIO-MED DEVICES; AIR-OXYGEN BLENDER

Model Number 2003

Device Problem Gas Output Problem (1266)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2014

Event Type  malfunction  

Event Description

See medwatch report # (b)(4) (we only received report from fda, not the user - we contacted the user facility thereafter) incorrect output oxygen % from blender in use - no injury to pt.

Manufacturer Narrative

Per (b)(6) ( biomed dept tech): device was repaired (with pm and cal) by (b)(4) of contract service company universal hosp services.He found the blender to have water inside.The device has been run off a portable compressor whose water trap ("moisture separating bowl") had been neglected, and not emptied.The blender ifu specifies that it must be used only with clean, cry medical grade gas inputs.(b)(4) plans to add a second water trap (that automatically drains) to their system.V.H.S.Reportedly did complete blender over haul (with bmd pm kit parts) and cleaned all calcium build up inside blender.This blender was never sent back to the mfr.

• Brand Name: BIO-MED DEVICES
• Type of Device: AIR-OXYGEN BLENDER
• Manufacturer (Section D): BIO-MED DEVICES, INC.; 61 soundview rd; guildford CT 06437
• Manufacturer Contact: 61 soundview rd; guildford, CT 06437 ; 2034580202
• MDR Report Key: 4203681
• MDR Text Key: 5148012
• Report Number: 1218704-2014-00004
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2003
• Device Catalogue Number: 2003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2014
• Initial Date FDA Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention