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U.S. Department of Health and Human Services

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

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SUNMED HOLDINGS LLC. STATCHECK RESUS BAG Back to Search Results
Model Number SC9200MBP-I
Device Problems Device Issue (2379); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/21/2018
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-2145-2018) for patient port assembly separating.
 
Event Description
The customer alleges that " the elbow disconnected during use" no other details were provided and no patient injury/harm reported.
 
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Brand NameSTATCHECK
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 Key7611018
MDR Text Key111985307
Report Number1314417-2018-00007
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
Remedial Action Recall
Type of Report Initial
Report Date 05/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSC9200MBP-I
Device Lot Number313447
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2018
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
Removal/Correction NumberZ-2145-2018

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