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Model Number AF1140MB
Device Problems Appropriate Term/Code Not Available (3191); Missing Value Reason (3192)
Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Event Date 04/13/2018
Event Type  malfunction  
Manufacturer Narrative
The affected device was returned. Functional testing of the device was performed and no abnormalities were observed. A visual inspection of the device was also performed and the following was observed: the product contained a white cap, the current product revision contains either a pop off valve or no cap. Additionally the returned product contained a green diaphragm valve seated within the tail end of the resus bag body in place of the current product's design which contains a red diaphragm valve. The white cap change was effective (b)(6) 2015 per (b)(4). The diaphragm valve color change was effective (b)(6) 2015 per (b)(4). These two visual indicators indicate that the product was manufactured prior to january 2015, using the old design components and therefore could not be the lot number that was reported by the end user. If the product was manufactured prior to january 2015 as supported by the visual indicators above, the product would also contain an old-design duckbill. The duckbill was re-designed and implemented in (b)(6) 2015 per (b)(4). The re-design of the duckbill was performed to change the material. This change was implemented due to prior customer complaints, sunmed capa(b)(4) and subsequent recall (dated (b)(6) 2014) for sticking/stuck duckbill and through validation (b)(4) demonstrated that the change corrected the sticking/stuck duckbill defect. Therefore, this device is believed to have been within the scope of the mentioned recall that was inadvertently not returned by the end user.
Event Description
The customer alleges that " the duckbill valve was sticking. " no other details were provided and no patient injury/harm reported.
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Type of DeviceRESUS BAG
Manufacturer (Section D)
2710 northridge dr. suite a
grand rapids MI 49544
Manufacturer (Section G)
2710 northridge dr. suite a
grand rapids MI 49544
Manufacturer Contact
carrie fortuna
2710 northridge dr. suite a
grand rapids, MI 49544
MDR Report Key7508273
MDR Text Key108264730
Report Number2246980-2018-00004
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 04/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF1140MB
Device Lot Number312332
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/13/2018
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