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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 AF2142MBP
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2020
Event Type  malfunction  
Manufacturer Narrative
The affected devices were not returned. The remaining 8 eaches out of the 10 eaches were sent back to us. The resuscitation bags were visually inspected and had no cracks on the patient valves or visible damage on the resuscitation bag that could cause the bag to be loud. The patient valves were inspected for leaking and there were no leaks. The resuscitation bags were also functionally tested sticky needle and they all passed. Due to no damaged product returned or pictures, the complaint is inconclusive.
 
Event Description
The customer alleges that "bvm loud, possible seal leak or sticking valve. " 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 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 Key9680942
MDR Text Key206569095
Report Number1314417-2020-00010
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 02/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF2142MBP
Device Lot Number319206
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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