MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCTS, INC. CHEMETRON; AIR FLOWMETER

Model Number 15002-13

Device Problem Inadequate User Interface (2958)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 07/19/2020

Event Type  Injury  

Event Description

Pt experienced cardiac arrest and subsequently expired.It was determined during the code that the resuscitation bag used for ventilation was connected to a medical air flowmeter instead of an oxygen flowmeter.The air flowmeter did not have standard yellow demarcations.

• Brand Name: CHEMETRON
• Type of Device: AIR FLOWMETER
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC.; 1750 s. brentwood blvd; ste 300
• MDR Report Key: 10351931
• MDR Text Key: 201254214
• Report Number: 10351931
• Device Sequence Number: 1
• Product Code: CAX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/28/2020,07/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15002-13
• Device Catalogue Number: 34-010136
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2020
• Distributor Facility Aware Date: 07/19/2020
• Device Age: 30 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BAG VALVE MASK
• Patient Age: 6 YR
• Patient Weight: 50