MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06,07 report with the FDA on 2013-04-12 for DETECTO IB-600 manufactured by Cardinal Scale Mfg. Inc.
[15201677]
This report is in response to report (b)(4). A (b)(6) female pt fell from a ib600 in bed pt lift scale while being transferred from one bed to another bed. On (b)(6) 2013 detecto scale rep, (b)(4), conducted an on-site investigation. The owner of the scale, (b)(6) hosp initially reported that a loading bar was bent and was concerned that perhaps the wrong bar was used sine the hosp had at least two different types of bar. Detecto has not been able to verify which bar was used but we do not feel that the bar, right or wrong, contributed to this incident. (b)(4) recorded the following observations during his on-site inspection: a nut was missing from a caster on the left scale leg. The anti-swing bars were not with the scale. Holes in the anti-swing mount were worn excessively. A plastic cup used to hold the stretcher was missing. During interviews with the staff personnel, (b)(4) discovered that two caregivers had tried unsuccessfully to move the pt from one bed to the other. They used the subject scale to lift the pt then moved the bed out from under the pt and were in the process of replacing it with another bed when the pt fell.
Patient Sequence No: 1, Text Type: D, B5
[15597748]
On-site visual inspection of actual scale was completed by (b)(4) acting as rep to defecto scale company. Based on this info, our analysis and the results of the on-site investigation, we have concluded that this incident resulted from failure to follow operating instructions provided with and attached to the scale. The scale is not to be used to transport a pt and is to have a bed beneath the pt during weighing operations. This instruction is both in the scale manual and attached to the scale itself. Further, the legs of the scale were not spread to a locked in the weighing position. Had the legs been in the weighing position, it would not have been possible to have slid the scale under the bed. Operating instructions clearly state that the scale legs must be spread to their full extension and locked in place before performing a weighing operation. This is necessary to maintain stability to conduct the weighing operation. Based on these observations and on-site inspection, it is our conclusion that this incident was not due to a defect in the scale.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1929045-2013-00001 |
| MDR Report Key | 3106785 |
| Report Source | 04,05,06,07 |
| Date Received | 2013-04-12 |
| Date of Report | 2013-04-11 |
| Date of Event | 2013-03-12 |
| Date Mfgr Received | 2013-03-15 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2013-05-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 203 EAST DAUGHERTY ST |
| Manufacturer City | WEBB CITY MO 64870 |
| Manufacturer Country | US |
| Manufacturer Postal | 64870 |
| Manufacturer Phone | 4176734631 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DETECTO |
| Generic Name | IN BED PATIENT LIFT SCALE |
| Product Code | FRW |
| Date Received | 2013-04-12 |
| Model Number | IB-600 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL SCALE MFG. INC |
| Manufacturer Address | 203 EAST DAUGHERTY ST WEBB CITY MO 64870 US 64870 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-12 |