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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 CPRM1116M
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2018
Event Type  malfunction  
Manufacturer Narrative
Resuscitation bag assembly returned had a blow molded mask with a deformed mask port. Only one of the received batch of product was found to have defect. The mask ports are 100% inspected during assembly, this defect occurred during transit. The time of manufacture meant that the box used was the j box, which had too short a box height. On (b)(6) 2018 was when co18-380 was implemented and switched this part number to c-s box, which has an extra couple inches in height.
 
Event Description
The customer alleges that "valve/port on the mask is misshaped. " 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 Key7827434
MDR Text Key118880543
Report Number1314417-2018-00019
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
Type of Report Initial
Report Date 08/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCPRM1116M
Device Lot Number314536
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
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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