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

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.

• Brand Name: DETECTO
• Type of Device: IN 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 Key: 5409758
• MDR Text Key: 37516186
• Report Number: 1929045-2016-00001
• Device Sequence Number: 1
• Product Code: FRW
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 01/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: IB600
• Device Catalogue Number: IB-600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other
• Patient Age: 68 YR
• Patient Weight: 85