MAUDE Adverse Event Report: BIO-MEDICAL DEVICES, INC. MAXAIR CONTROLLED AIR PURIFYING RESPIRATOR (CAPR) SYSTEM; GOWN, SURGICAL

Model Number 2080-03

Device Problems Crack (1135); Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 12/08/2020

Event Type  malfunction  

Event Description

Ed staff reported disposable face shields on new controlled air purifying respirators (caprs) popped off during patient care, discovered that there is a defect in the capr with a mis-spaced pin to attach the face shield, leading the shields to crack and interrupt the integrity of the securement device.The defect is significant and really concerning.The button onto which the "lens" (face shield) is supposed to snap is 3-4 mm too far away.This results in decreased integrity of the connection and puts staff/providers at risk for harm.Being told by a representative that, "a little tearing is to be expected".Manufacturer response for caprs and helmet liner, caprs and helmet liner (per site reporter) we escalated to maxair rep for review.Caprs removed from use.Per representative, there is a known defect on our lot # of caprs - company will be replacing all of our caprs.

• Brand Name: MAXAIR CONTROLLED AIR PURIFYING RESPIRATOR (CAPR) SYSTEM
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): BIO-MEDICAL DEVICES, INC.; 17171 daimer street; irvine CA 92614
• MDR Report Key: 11139360
• MDR Text Key: 225753935
• Report Number: 11139360
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2020,12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2080-03
• Device Catalogue Number: 2080-03
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2020
• Date Report to Manufacturer: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1