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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 AF5140MBS-M5
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/02/2019
Event Type  malfunction  
Manufacturer Narrative
Affected product was returned.The exhalation port was confirmed detached from the patient valve.The bv filter was still attached to the exhalation port which confirms that the breakage occurred after assembly.The valve would still be functional, however, the bv filter would not be usable with the resuscitation bag.Customer complaint was confirmed.
 
Event Description
The customer alleges the "exhalation port was broken off." no other details were provided and no patient injury/harm reported.
 
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Brand Name
AIRFLOW
Type of Device
MANUAL 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 Key8645507
MDR Text Key146359000
Report Number1314417-2019-00033
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberAF5140MBS-M5
Device Lot Number317561
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2019
Was Device Evaluated by Manufacturer? Yes
Type of Device Usage N
Patient Sequence Number1
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