MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-01-27 for DETECTO IB600 IB-600 manufactured by Cardinal Detecto Scale Company.
[37516186]
The actual device from the incident was inspected by a cardinal representative. The device is working and labeled properly.
Patient Sequence No: 1, Text Type: N, H10
[37516187]
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.
Patient Sequence No: 1, Text Type: D, B5
[66880551]
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.
Patient Sequence No: 1, Text Type: N, H10
[66880552]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1929045-2016-00001 |
| MDR Report Key | 5409758 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-01-27 |
| Date of Report | 2016-06-21 |
| Date of Event | 2016-06-09 |
| Date Mfgr Received | 2016-07-01 |
| Device Manufacturer Date | 2008-11-10 |
| Date Added to Maude | 2016-02-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | SERVICE AND TESTING PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARK LEVELS |
| Manufacturer Street | 203 E DAUGHERTY ST |
| Manufacturer City | WEBB CITY MO 64870 |
| Manufacturer Country | US |
| Manufacturer Postal | 64870 |
| Manufacturer Phone | 4176734631 |
| Manufacturer G1 | CARDINAL DETECTO SCALE COMPANY |
| Manufacturer Street | 203 E DAUGHERTY ST |
| Manufacturer City | WEBB CITY MO 64870 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 64870 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DETECTO |
| Generic Name | IN BED PATIENT SCALE |
| Product Code | FRW |
| Date Received | 2016-01-27 |
| Model Number | IB600 |
| Catalog Number | IB-600 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL DETECTO SCALE COMPANY |
| Manufacturer Address | 203 E DAUGHERTY ST WEBB CITY MO 64870 US 64870 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Other | 2016-01-27 |