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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIR TECHNIQUES INC. MONARCH DISINFECTANT MEDICAL DEVICE

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AIR TECHNIQUES INC. MONARCH DISINFECTANT MEDICAL DEVICE Back to Search Results
Model Number H6340
Device Problems Product Quality Problem (1506); Device Contamination With Biological Material (2908); Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 02/21/2018
Event Type  malfunction  
Manufacturer Narrative
On 3/20/2018 product is currently being evaluated by supplier. Scar # (b)(4) was issued to supplier on 3/2/2018. On 5/25/2018 report was previously submitted on time with successful ack3s responses but on 5/23/2018 we noticed that the mfr report # on the original report was incorrect. We have corrected the mfr report # (2428225-2018-00002. ).
 
Event Description
Office opened 2 bottles of line cleaner and noticed that there was mold in the bottles.
 
Event Description
Office opened 2 bottles of line cleaner and noticed that there was mold in the bottles.
 
Manufacturer Narrative
8/1/2018 (b)(4) (supplier) sent the bottles to an external lab 'accelerated analytical laboratories (aal)' to identify the contamination. Aal protocol revealed that at the time of receipt the foreign material was non-viable. Aal reports that the foreign material appears from the microscopic review to be visually similar to mold however this was not confirmed microbiologically. Per the report, the active ingredients of the bottle inhibit the growth of the mold. Therefore, it is believed that the material (possibly mold) was most likely introduced in the bottles from an external source. (b)(4).
 
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Brand NameMONARCH
Type of DeviceDISINFECTANT MEDICAL DEVICE
Manufacturer (Section D)
AIR TECHNIQUES INC.
1295 walt whitman road
melville NY 11747
MDR Report Key7554707
MDR Text Key109773336
Report Number2428225-2018-00002
Device Sequence Number1
Product Code LRJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 02/22/2018,08/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH6340
Device Catalogue NumberH6340
Device Lot NumberG289
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2018
Was the Report Sent to FDA? No
Event Location Other
Date Report to Manufacturer02/22/2018
Date Manufacturer Received02/21/2018
Is This a Reprocessed and Reused Single-Use Device? No

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