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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 AF5140MB
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2019
Event Type  malfunction  
Manufacturer Narrative
The returned product confirms the customers complaint description. The patient port swivel was separated from the patient valve but was not returned with the device to evaluate nor was the mask that was attached to the patient port swivel.
 
Event Description
The customer alleges that " bag breaking at patient connection site when trying to disconnect the mask, no patient injury. " 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 Key9590760
MDR Text Key221294224
Report Number1314417-2020-00002
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 01/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF5140MB
Device Lot Number319904
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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