• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNMED HOLDINGS, LLC. AIRFLOW MANUAL RESUSCITATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SUNMED HOLDINGS, LLC. AIRFLOW MANUAL RESUSCITATOR Back to Search Results
Model Number AF5140MB
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/09/2019
Event Type  malfunction  
Manufacturer Narrative
No product was returned, the lot number provided by the customer, 0004020695, is invalid and can not be tracked back to sunmed ap or sunmed gr, thus batch record review is not possible. Engineering visually inspected (qty 20) bags of af5140mb from lot # 319551 to verify that the mask was included in the bag. All (qty 20) bags of af5140mb had the mask included in the bag. The investigation is inconclusive.
 
Event Description
The customer alleges that "no mask in the bag that contains the resuscitator. " no other details were provided and no patient injury/harm reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAIRFLOW
Type of DeviceMANUAL RESUSCITATOR
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 Key8955454
MDR Text Key191468748
Report Number1314417-2019-00048
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 09/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF5140MB
Device Lot Number00204020695
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

-
-