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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 Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/23/2019
Event Type  malfunction  
Manufacturer Narrative
The customer noted that they had several occurences but the product was thrown away. No photographs were provided as evidence of the defect however, based on the described customer complaint, this is an ongoing issue that is being addressed per internal capa.
 
Event Description
The customer alleges that "mask is not fitting the bag properly. " 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 Key9641933
MDR Text Key221028620
Report Number1314417-2020-00006
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 01/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF5140MB
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? 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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