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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNMED HOLDINGS, LLC. AIRFLOW MANUAL RESUSCITATOR

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SUNMED HOLDINGS, LLC. AIRFLOW MANUAL RESUSCITATOR Back to Search Results
Model Number AF5140MC
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/28/2020
Event Type  malfunction  
Manufacturer Narrative
The returned devices were confirmed to be broken upon receiving inspection. The customer did not provide enough detail to determine when the damage occurred. This type of damage is believed to be a result of blunt force such as a drop or transit damage. Based on the lot dates of the product returned this is likely product that was not within new and improved divided boxes that help protect product from this type of damage. The customer complaint is confirmed.
 
Event Description
The customer alleges that "resuscitators are breaking. " no other details were provided and no patient injury/harm reported.
 
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Brand NameAIRFLOW
Type of DeviceMANUAL RESUSCITATOR
Manufacturer (Section D)
SUNMED HOLDINGS, LLC.
2710 northridge dr. nw.
suite a
grand rapids, mi
Manufacturer (Section G)
SUNMED HOLDINGS LLC.
2710 northridge dr. nw
suite a
grand rapids, mi
Manufacturer Contact
carrie fortuna
2710 northridge dr. nw.
suite a
grand rapids, mi 
2598400
MDR Report Key9746436
MDR Text Key200482702
Report Number1314417-2020-00012
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
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 02/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF5140MC
Device Lot Number318655
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
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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