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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL BREATHING PORTEX OXYGEN/AEROSOL MASK KITS; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
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NULL BREATHING PORTEX OXYGEN/AEROSOL MASK KITS; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY Back to Search Results
Catalog Number 001121
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2020
Event Type  malfunction  
Manufacturer Narrative
Udi information is unknown.Operator of device is unknown.No information has been provided to date.Manufacturing site address is unknown.Premarket (510k) number is unknown.A device history record (dhr) review was conducted at the supplier site.A product sample was received for evaluation at the supplier site.Visual and functional testing were performed by the supplier.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
 
Event Description
It was reported that immediately after opening package, customer observed the connection between mask and tube was disconnected.No patient injury was reported.
 
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Brand Name
BREATHING PORTEX OXYGEN/AEROSOL MASK KITS
Type of Device
AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
Manufacturer (Section G)
NULL
MDR Report Key15462515
MDR Text Key305537612
Report Number3012307300-2022-20006
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number001121
Device Lot Number1910251A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/07/2022
Initial Date FDA Received09/22/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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