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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNMED Medline Industries, Inc. RESUS BAG

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SUNMED Medline Industries, Inc. RESUS BAG Back to Search Results
Model Number CPRM1116
Device Problems Device Issue (2379); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Event Type  malfunction  
Manufacturer Narrative
Customer returned affected device. Customer claim was confirmed through initial observations of returned device. Although the claim can be confirmed the failure mode and root cause is unknown at this time further investigation needed and a nonconformance has been opened to further investigate this defect.
 
Event Description
The customer alleges that " elbow broke off resus bag. " no other details were provided and no patient injury/harm reported.
 
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Brand NameMedline Industries, Inc.
Type of DeviceRESUS BAG
Manufacturer (Section D)
SUNMED
2710 northridge dr. suite a
grand rapids MI 49544
Manufacturer (Section G)
VENTLAB
2710 northridge dr. suite a
grand rapids MI 49544
Manufacturer Contact
carrie fortuna
2710 northridge dr. suite a
grand rapids, MI 49544
6162598400
MDR Report Key7487810
MDR Text Key107994791
Report Number2246980-2018-00003
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 05/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCPRM1116
Device Catalogue NumberCPRM1116
Device Lot Number313297
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
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

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