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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNMED HOLDINGS LLC. AIRFLOW RESUSCITATOR

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SUNMED HOLDINGS LLC. AIRFLOW RESUSCITATOR Back to Search Results
Model Number AF3140MB
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2019
Event Type  malfunction  
Manufacturer Narrative
A review of the batch record was performed and no abnormalities were noted. No rejects or inspection notes on the o2 port condition were observed. The affected device was not returned however a picture was provided. Visual inspection of the affected product through provided picture did confirm that the o2 port on the tail valve was broken.
 
Event Description
The customer alleges the "ambu bag on peds malfunctioned''. No other details were provided and no patient injury/harm reported.
 
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Brand NameAIRFLOW
Type of DeviceRESUSCITATOR
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 Key8505610
MDR Text Key143601832
Report Number1314417-2019-00016
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 04/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF3140MB
Device Lot Number316974
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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