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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNMED HOLDINGS LLC. AIRFLOW; RESUSCITATION BAG
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SUNMED HOLDINGS LLC. AIRFLOW; RESUSCITATION BAG Back to Search Results
Model Number AF5140MBS
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems No Code Available (3191); Missing Value Reason (3192)
Event Date 11/26/2018
Event Type  malfunction  
Manufacturer Narrative
The affected product was not returned so an inventory evaluation was performed.Samples selected for the inventory evaluation were opened and inspected for port out of roundness.In addition, the parts were checked for fit to the patient port of the resuscitation bag.No failures found.Customer complaint could not be confirmed.
 
Event Description
The customer alleges that "valve port on mask is misshapen and does not fit into resus bag".No other details were provided and no patient injury/harm reported.
 
Manufacturer Narrative
The affected product was returned and a product evaluation was performed.Their was a slight mask port deformation present in 1 out of 2 samples returned.The part was still able to fit onto the patient valve with light force, the customer complaint could be confirmed visually.
 
Event Description
The customer alleges that "valve port on mask is misshapen and does not fit into resus bag." no other details were provided and no patient injury/harm reported.
 
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Brand Name
AIRFLOW
Type of Device
RESUSCITATION BAG
Manufacturer (Section D)
SUNMED HOLDINGS LLC.
2710 northridge dr. nw
suite a
grand rapids MI 49544
MDR Report Key8221720
MDR Text Key132227996
Report Number1314417-2019-00001
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 03/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberAF5140MBS
Device Lot Number314480
Was Device Available for Evaluation? No
Patient Sequence Number1
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