MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-31 for LIFESTAND LSA HELIUM N/A manufactured by Permobil Inc..
[134654899]
The end-user claims when the incident occurred, they were seated in the device with their legs being secured by the knee block assembly. As they were repositioning, the left side back frame broke causing the end-user to lose positioning and fall to the left side. As their legs were secured, it is speculated the leg twisted when their weight fell to the left side causing a reported proximal tibia/fibula fracture to the left leg. Review of photos supplied by the reporter indicate the left side of the back support frame broke in half. Review of the dhr indicates the device had previously been broken to where the right side seat frame needed replacement. Investigation shown that components to properly repair the device had been ordered, but had not been installed on the device prior to this reported event having occurred. Interviews with veterans administration physical therapist confirmed the end-user continued to utilize the device after being advised, on multiple occasions, to refrain from use and to utilize an alternative device until service could be completed. It is permobil's contention that with the end-user continuing to utilize the device in a diminished state, excessive forces were applied unevenly across the back frame, causing stress, leading to eventual material fatigue of the back frame material. As the device has exceeded 5 years in age, reports indicate the device is being evaluated for replacement vs. Repair. The dhr was reviewed and device met specification prior to distribution.
Patient Sequence No: 1, Text Type: N, H10
[134654900]
Permobil received report claiming as end-user was repositioning itself in the seating, the left side back frame broke causing the end-user to lose positioning and fall to the side. It was reported the end-user had their legs secured to the device and when they fell to the side, caused a reported fracture to the left tibia and fibula.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221084-2019-00006 |
| MDR Report Key | 8294464 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-31 |
| Date of Event | 2018-11-30 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2013-09-16 |
| Date Added to Maude | 2019-01-31 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KEVIN BULLOCK |
| Manufacturer Street | 300 DUKE DRIVE |
| Manufacturer City | LEBANON TN 37090 |
| Manufacturer Country | US |
| Manufacturer Postal | 37090 |
| Manufacturer Phone | 8007360925 |
| Manufacturer G1 | PERMOBIL INC. |
| Manufacturer Street | 300 DUKE DRIVE |
| Manufacturer City | LEBANON TN 37090 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37090 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFESTAND LSA HELIUM |
| Generic Name | MANUALLY PROPELLED STANDUP WHEELCHAIR |
| Product Code | IPL |
| Date Received | 2019-01-31 |
| Model Number | LSA HELIUM |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERMOBIL INC. |
| Manufacturer Address | 300 DUKE DRIVE LEBANON TN 37090 US 37090 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-01-31 |