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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 AF1140MB-P
Device Problem Material Deformation (2976)
Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Event Date 08/04/2018
Event Type  malfunction  
Manufacturer Narrative
Customer did return affected devices and the investigator can confirm customer claim, a nonconformance has been opened to further investigate this defect.
 
Event Description
The customer alleges that "the connector on the mask is warped. " no other details were provided and no patient injury/harm reported.
 
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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 Key7901811
MDR Text Key121467512
Report Number1314417-2018-00032
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF1140MB-P
Device Lot Number314365
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2018
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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