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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNMED HOLDINGS, LLC. MEDLINE MANUAL RESUSCITATOR

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SUNMED HOLDINGS, LLC. MEDLINE MANUAL RESUSCITATOR Back to Search Results
Model Number CPRM1116M
Device Problem Material Deformation (2976)
Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Event Date 08/15/2018
Event Type  malfunction  
Manufacturer Narrative
The customer alleges that "the port on the mask is deformed/warped. " no other details were provided and no patient injury/harm reported. Affected product was not returned but a photo of the defective product was provided. The investigator was able to confirm the customer claim by studying the photograph.
 
Event Description
The customer alleges that "the port on the mask is deformed/warped. " no other details were provided and no patient injury/harm reported.
 
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Brand NameMEDLINE
Type of DeviceMANUAL RESUSCITATOR
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 Key7890154
MDR Text Key120834292
Report Number1314417-2018-00031
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 Non-Healthcare Professional
Type of Report Initial
Report Date 08/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCPRM1116M
Device Lot Number314461
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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