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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DANYANG MAXTHAI MEDICAL EQUIPMENT MECHANICAL CHAIR/TRANSPORT CHAIR; 890.3100

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DANYANG MAXTHAI MEDICAL EQUIPMENT MECHANICAL CHAIR/TRANSPORT CHAIR; 890.3100 Back to Search Results
Model Number LTTR19FR
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Per dealer, the front rigging had a broken weld where it connects to the chair.
 
Manufacturer Narrative
 
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Brand Name
MECHANICAL CHAIR/TRANSPORT CHAIR
Type of Device
890.3100
Manufacturer (Section D)
DANYANG MAXTHAI MEDICAL EQUIPMENT
danyang
CH 
Manufacturer (Section G)
DANYANG MAXTHAI MEDICAL EQUIPMENT
danyang
CH  
Manufacturer Contact
patricia medina
one invacare way
elyria, OH 44035
8003336900
MDR Report Key3643629
MDR Text Key4348580
Report Number1531186-2014-00607
Device Sequence Number1
Product Code INM
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 Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 02/05/2014
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 Lay User/Patient
Device Model NumberLTTR19FR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/05/2014
Initial Date FDA Received02/24/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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