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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNMED HOLDINGS LLC. SAFESPOT; MANUAL RESUSCITATOR
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SUNMED HOLDINGS LLC. SAFESPOT; MANUAL RESUSCITATOR Back to Search Results
Model Number SS32000OB
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/04/2019
Event Type  malfunction  
Manufacturer Narrative
The product sent back matches a specification from a previous revision dating back to at least 2011.The size of the port id slightly changed to the latest revision but matches sunmeds inner diameter specification.Given the standard inner diameter matches sunmeds specification requirements there is no fault found with the design and/or physical product returned and reported as bad per the customer complaint.Bs en 13544-2:2002 part 2: tubing and connectors provides guidance for connector diameter size and reflects what was designed into sunmed's fits-all-connector.
 
Event Description
The customer alleges that " the o2 tubing will not stay on the opening for the flow meter." no other details were provided and no patient injury/harm reported.
 
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Brand Name
SAFESPOT
Type of Device
MANUAL 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 Key9279801
MDR Text Key216661212
Report Number1314417-2019-00058
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 Non-Healthcare Professional
Type of Report Initial
Report Date 11/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberSS32000OB
Device Lot Number317960
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2019
Was Device Evaluated by Manufacturer? Yes
Type of Device Usage N
Patient Sequence Number1
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