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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 AF1140MB
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/23/2019
Event Type  malfunction  
Manufacturer Narrative
The returned device was confirmed to be broken however the cause for the device breaking is not known but believed to be from factors outside of sunmed manufacturing practices such as blunt force from dropping, accidental contact with a hard surface, or transit handling. There is no reason to believe that there is a manufacturing or product design issue as the occurrence is one part. Sunmed has tested product against iso10651-4 section 5. 4. 1 drop test and found that the product meets the iso requirements.
 
Event Description
The customer alleges that "an airflow adult resuscitator w/manometer, filter, mask and bag that was defective. The end of the green unit that is hard plastic, looks like it was broken off. ".
 
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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 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 Key9636223
MDR Text Key200796588
Report Number1314417-2020-00004
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
Report Date 01/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF1140MB
Device Lot Number317144
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2020
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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