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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 CPRM2216PMT
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 Date 05/21/2018
Event Type  malfunction  
Manufacturer Narrative
Customer returned affected product for evaluation.Although the lot numbers were not provided, the investigator was able to assess affected product.The affected product was visually and functionally inspected.Investigation results confirms product functioned as intended.
 
Event Description
The customer alleges that "the resus bag was not registering peep." no other details were provided.
 
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Brand Name
MEDLINE
Type of Device
RESUS 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 Key7651210
MDR Text Key112850622
Report Number1314417-2018-00010
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 06/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberCPRM2216PMT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Was Device Evaluated by Manufacturer? Yes
Type of Device Usage N
Patient Sequence Number1
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