MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-19 for MPS SEATING SYSTEM PS20=RB-345 manufactured by Otto Bock Healthcare Lp.
[50729498]
Per the ifu, the back adjustment was specified to be checked on a monthly basis without the user in the chair. Also, we recommend checking the product settings regularly in order to assure an optimum fit over the long term since this product is expected to be used over time. For growing children and youths in particular, fitting should be performed every six months. Also, with the child's condition it is recommended to check the chair configuration regularly to ensure proper form, fit and function.
Patient Sequence No: 1, Text Type: N, H10
[50729499]
The patient became excited, jerked and flexed his body backwards applying significant force to the backrest while sitting in the chair. The backrest on the mps system broke in half and the patient fell backwards in the chair. The backrest was stabilized horizontally with the seat and held the patient above the ground in this position because the straps were in position to hold both the back and the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721652-2016-00001 |
| MDR Report Key | 5803649 |
| Date Received | 2016-07-19 |
| Date of Report | 2016-04-18 |
| Date of Event | 2016-03-08 |
| Date Mfgr Received | 2016-03-14 |
| Device Manufacturer Date | 2013-12-03 |
| Date Added to Maude | 2016-07-19 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CALEB BECK |
| Manufacturer Street | 3820 WEST GREAT LAKES DRIVE |
| Manufacturer City | WEST VALLEY CITY UT 84120 |
| Manufacturer Country | US |
| Manufacturer Postal | 84120 |
| Manufacturer Phone | 8019746647 |
| Manufacturer G1 | OTTO BOCK HEALTHCARE LP |
| Manufacturer Street | 3820 WEST GREAT LAKES DRIVE |
| Manufacturer City | WEST VALLEY CITY UT 84120 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MPS SEATING SYSTEM |
| Generic Name | WHEELCHAIR COMPONENTS |
| Product Code | KNN |
| Date Received | 2016-07-19 |
| Returned To Mfg | 2016-03-24 |
| Model Number | PS20=RB-345 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTTO BOCK HEALTHCARE LP |
| Manufacturer Address | 3820 WEST GREAT LAKES DRIVE WEST VALLEY CITY UT 84120 US 84120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-19 |