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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 09/06/2019
Event Type  malfunction  
Manufacturer Narrative
The suspect devices were returned and the mask port was confirmed out of round via a visual inspection. The degree of out of round varied. In all instances the mask port was still able to connect to the patient port on the device.
 
Event Description
The customer alleges that "the 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 Key9157771
MDR Text Key191469879
Report Number1314417-2019-00054
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 10/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF1140MBS
Device Lot Number318640
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

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