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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNMED HOLDINGS, LLC VENTLAB VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

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SUNMED HOLDINGS, LLC VENTLAB VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
Model Number AF1140MB
Device Problem Deflation Problem (1149)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/20/2018
Event Type  malfunction  
Event Description
Respiratory therapy staff informed director they needed to inflate the mask that comes with the ambu bags but they have been quite flat. Director looked at the er par level and identified 3 ambu bags total with the same issue. They were of the same lot # (310173) and manufactured on the same date and they seemed to deflate a bit over time. Director also checked the crash carts and found 2 additional ones with same lot #. Director removed them and took to supply chain. Replacements given.
 
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Brand NameVENTLAB
Type of DeviceVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Manufacturer (Section D)
SUNMED HOLDINGS, LLC
2710 northridge drive nw suite a
grand rapids MI 49544
MDR Report Key7845458
MDR Text Key119236150
Report Number7845458
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/23/2018,08/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/05/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF1140MB
Device Catalogue NumberAF1140MB
Device Lot Number310173
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/23/2018
Event Location Hospital
Date Report to Manufacturer09/05/2018
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? No
Type of Device Usage

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