MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-04-07 for PATIENT SCALE M3813B manufactured by Philips Healthcare.
[1112183]
The customer reported that a condition exists with the m3812b philips scale device where the feet on the scale platform are broken after a patient fall. Customer reported that patient damaged the scale by wobbling and then falling, but philips wants to ensure that the device did not contribute to the fall.
Patient Sequence No: 1, Text Type: D, B5
[8296299]
We replaced the unit for this patient. Further investigation into this matter is ongoing. To date, no conclusion can be made in regard to whether device caused patient to fall from the scale. Patient's daughter, and our customer have reported that the broken feet on the platform are a result of the patient fall, and not vice versa. Patient's daughter states: "scale was damaged because the fall caused the scale to tip up and two of the feet were damaged". Our initial investigation cannot conclude, however, that the unit was damaged by, and did not cause, the fall. We have initiated a corrective action investigation to further evaluate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2009-00412 |
| MDR Report Key | 1435994 |
| Report Source | 05 |
| Date Received | 2009-04-07 |
| Date of Report | 2009-03-02 |
| Date Mfgr Received | 2009-04-03 |
| Date Added to Maude | 2009-09-09 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CYNTHIA DROVER |
| Manufacturer Street | 3000 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786592619 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATIENT SCALE |
| Product Code | FRW |
| Date Received | 2009-04-07 |
| Returned To Mfg | 2009-04-03 |
| Model Number | M3813B |
| Catalog Number | M3813B |
| Lot Number | 3813B0006327 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS HEALTHCARE |
| Manufacturer Address | 3000 MINUTEMAN RD. ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-07 |