• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SUNMED HOLDINGS LLC. RESUCUMED RESUS BAG Back to Search Results
Model Number BVMB510S-F
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/10/2019
Event Type  malfunction  
Manufacturer Narrative
No product was returned. Batch record review was performed and operator interview confirmed that procedure for assembling and packaging was followed. An inventory evaluation of the same part number had masks included as expected. The investigation is inconclusive.
 
Event Description
The customer alleges that "resus bag is missing the mask". No other details were provided and no patient injury/harm reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESUCUMED
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 Key8411728
MDR Text Key139190867
Report Number1314417-2019-00008
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
Reporter Occupation
Type of Report Initial
Report Date 02/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBVMB510S-F
Device Lot Number317003
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/12/2019 Patient Sequence Number: 1
-
-