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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEVEL 1; HOTLINE LOW FLOW SYSTEM
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LEVEL 1; HOTLINE LOW FLOW SYSTEM Back to Search Results
Catalog Number CON-HL-90
Device Problem Defective Component (2292)
Patient Problem No Information (3190)
Event Date 08/19/2020
Event Type  malfunction  
Event Description
Information was received that one of the internal adjustment components broke off.No adverse effects reported.
 
Manufacturer Narrative
Returned device was received in poor physical condition.The tank cover was cracked and the pcb and power switch were outdated.During the evaluation of the device, the issue was able to be replicated and this was determined to be caused by loose parts from the pcb falling off.The damage found is consistent with the customer not being gentle when adjusting delicate equipment.This device was determined to be beyond repair.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
Manufacturer Narrative
Additional information was received indicating there was no patient involvement.The product problem was observed during testing.The unit did not alarm.The event was discovered on (b)(6) 2020.
 
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Brand Name
LEVEL 1
Type of Device
HOTLINE LOW FLOW SYSTEM
MDR Report Key10503013
MDR Text Key205953499
Report Number3012307300-2020-09079
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/19/2020
Initial Date FDA Received09/08/2020
Supplement Dates Manufacturer Received09/15/2020
11/20/2020
Supplement Dates FDA Received10/06/2020
12/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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