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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNMED HOLDINGS LLC. MEDLINE RESUS BAG

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SUNMED HOLDINGS LLC. MEDLINE RESUS BAG Back to Search Results
Model Number CPRM1126
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
The affected device was returned and the defect was confirmed. The affected device falls within the scope of recall (z-2152-2018) for patient port assembly separating.
 
Event Description
The customer alleges that " the elbow breaking on the resus bag. " no other details were provided and no patient injury/harm reported.
 
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Brand NameMEDLINE
Type of DeviceRESUS BAG
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 Key7629044
MDR Text Key112048841
Report Number1314417-2018-00009
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
Source Type distributor
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 05/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCPRM1126
Device Catalogue NumberCPRM1126
Device Lot Number309617
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/12/2018
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
Removal/Correction NumberZ-2152-2018

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