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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL DETECTO SCALE COMPANY DETECTO IN BED PATIENT SCALE

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CARDINAL DETECTO SCALE COMPANY DETECTO IN BED PATIENT SCALE Back to Search Results
Model Number IB600
Device Problems Improper or Incorrect Procedure or Method (2017); Device Tipped Over (2589)
Patient Problems Death (1802); Head Injury (1879)
Event Date 06/09/2016
Event Type  Death  
Manufacturer Narrative
The actual device from the incident was inspected by a cardinal representative. The device is working and labeled properly.
 
Event Description
On 12/23/2015 cardinal/detecto became aware of an incident involving the use of an ib-600 patient lift scale. As described via email to one of our regional sales managers, a terminally ill patient was in the care of hospice at the facility. The staff was attempting to change the mattress for the patient and used the scale to lift and move the patient while this was occurring. The cna doing this did not wait for assistance and did not fully expand the base of the scale. At this point, the scale tipped over and the patient hit her head. The patient was then transferred to another facility and passed two days later. At the time of this report, the cause of death is not known by cardinal scale. The cardinal regional sales manager did visit the facility and met with the staff. His inspection of the device was that it is not a "transport device" and that not operating the scale properly could result in serious patient injury. Pictures were taken of the labeling and of the instructions attached to the device. They are included in this report. It is our conclusion that this device was not used in its' original intended function and was not the cause of the injury to the patient.
 
Manufacturer Narrative
Cardinal/detecto scale made several attempts to contact (b)(6) to set up an evaluation of the suspect device via onsite or by return of the product. Neither party would discuss the issue with the scale and would not return any messages. Detecto is unable to properly evaluate the scale/device for proper function. Device not available.
 
Event Description
Received medwatch (mw5063002) that when attempting to weigh patient on a lift weight scale the lock on the legs supports unhitched causing legs of the scale to move to the center and the scale tipped over to side.
 
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Brand NameDETECTO
Type of DeviceIN BED PATIENT SCALE
Manufacturer (Section D)
CARDINAL DETECTO SCALE COMPANY
203 e daugherty st
webb city MO 64870
Manufacturer (Section G)
CARDINAL DETECTO SCALE COMPANY
203 e daugherty st
webb city MO 64870
Manufacturer Contact
mark levels
203 e daugherty st
webb city, MO 64870
4176734631
MDR Report Key5409758
MDR Text Key37516186
Report Number1929045-2016-00001
Device Sequence Number1
Product Code FRW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Service and Testing Personnel
Type of Report Initial,Followup
Report Date 06/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberIB600
Device Catalogue NumberIB-600
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/10/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/27/2016 Patient Sequence Number: 1
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