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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTLAB LLC. RESUS BAG

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VENTLAB LLC. RESUS BAG Back to Search Results
Model Number CPRM1116
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Death (1802)
Event Date 01/05/2017
Event Type  Death  
Manufacturer Narrative
The affected device was not returned for evaluation however every mask that sunmed manufacturers is checked for inflation before it is placed into a resuscitation kit. If the inflation of a mask is determined to be low, the production operators will re-inflate it per the approved work instructions. If a mask is determined to be flat it will be scrapped. The customer did not complain about the masks being deflated. The complaint stated that the masks did not provide a good seal around the patient's face. The mask in question is an adult mask that is relatively large in size. This complaint originated in a nursing home so it feasible that the mask was not the correct size for the patient. This might explain why the customer had the same problem with two masks that were used back-to back. Overall there is not enough information to state that the devices did not meet a specified requirement or malfunctioned.
 
Event Description
The customer alleges "the mask on the resus bag did not provide a proper seal around the patient's face. " the customer also states that a second mask was retrieved and the same issue occurred. The resident was subsequently transported to the emergency room and died.
 
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Type of DeviceRESUS BAG
Manufacturer (Section D)
VENTLAB LLC.
2710 northridgedr. suite a
grand rapids MI 49544
Manufacturer (Section G)
VENTLAB LLC.
2710 northridgedr. suite a
grand rapids MI 49544
Manufacturer Contact
carrie fortuna
2710 northridge dr. suite a
grand rapids, MI 49544
6162598350
MDR Report Key6366180
MDR Text Key68593032
Report Number2246980-2017-00011
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
Type of Report Initial
Report Date 02/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberCPRM1116
Device Lot Number306996
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2016
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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