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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNMED HOLDINGS, LLC. AIRFLOW RESUS BAG

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SUNMED HOLDINGS, LLC. AIRFLOW RESUS BAG Back to Search Results
Model Number AF1140MBS
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/30/2019
Event Type  malfunction  
Manufacturer Narrative
The suspect devices were returned and the mask port was confirmed out of round via a visual inspection. The mask ports are 100% inspected during assembly therefore this defect occurred during transit. The mask port was still able to connect to the patient port on the device.
 
Event Description
The customer alleges that "connection from bag to mask was unable to slip together, it was too tight. " no other details were provided.
 
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Brand NameAIRFLOW
Type of DeviceRESUS BAG
Manufacturer (Section D)
SUNMED HOLDINGS, LLC.
2710 northridge dr. nw.
suite a
grand rapids MI 49544
Manufacturer (Section G)
SUNMED HOLDINGS LLC.
2710 northridge dr. nw
suite a
grand rapids MI 49544
Manufacturer Contact
carrie fortuna
2710 northridge dr. nw.
suite a
grand rapids, MI 49544
6162598400
MDR Report Key9130217
MDR Text Key191469551
Report Number1314417-2019-00052
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 09/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF1140MBS
Device Lot Number314472
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/27/2019 Patient Sequence Number: 1
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