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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. KINAIRMEDSURG

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ARJOHUNTLEIGH INC. KINAIRMEDSURG Back to Search Results
Model Number 201001W
Device Problems Break (1069); Device Inoperable (1663)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 03/18/2014
Event Type  malfunction  
Event Description
Initially, it has been claimed that the kinairmedsurg was falling apart.The person who raised the complaint stated that bed was broken and its bottom was sticking out.No information about patient involvement was provided.Although none of currently available information suggest that an injury occurred in relation to this event we cannot exclude the possibility that during the reoccurrence a serious injury might occur.
 
Manufacturer Narrative
(b)(4).As a consequence of issue with the integration of the former kci rental business into arjohuntleigh and challenges from i.E.It perspective we were forced to a more manual process to screen service data for complaints.We have realized that this process did not detect all complaints and that arjohuntleigh have failed to get them all timely into our complaint handling system.Unfortunately, as a result of a retrospective review after this finding we have identified this reportable complaint that is filed late.As a consequence of the complaint being old we have limited information on the event while additional effort to obtain data has been performed.We will continue our efforts to complete this investigation.A capa has been initiated to document the efforts to complete investigations, and implement corrects and corrective actions.Additional information will be provided upon conclusion of the investigation.
 
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Brand Name
KINAIRMEDSURG
Manufacturer (Section D)
ARJOHUNTLEIGH INC.
4958 stout drive
san antonio TX 78219
Manufacturer (Section G)
ARJOHUNTLEIGH INC.
4958 stout drive
san antonio TX 78219
Manufacturer Contact
pamela wright
12625 wetmore rd ste 308
san antonio, TX 78247
2102787040
MDR Report Key4652104
MDR Text Key5759574
Report Number3009988881-2015-00017
Device Sequence Number1
Product Code INX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Remedial Action Inspection
Type of Report Initial
Report Date 03/18/2014
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 Other
Device Model Number201001W
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/18/2014
Initial Date FDA Received04/01/2015
Was Device Evaluated by Manufacturer? No
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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