MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-11-07 for LIFESTAND LSA HELIUM N/A manufactured by Permobil Inc..
[126419176]
The end-user reported having just performed a side transfer into the lifestand helium from another manual wheelchair and were positioned at the front edge of the seating. The end-user described putting their hands at the sides to lift their body to reposition farther back into the seating. While performing this act, the end-user reports the seating went into a stand position which caused them to lose their balance and fall to the floor. End-user reported having called emergency services to where they were transported to the local hospital for evaluation. End-user was diagnosed as suffering distal fractures to both femurs requiring surgery. The wheelchair was evaluated, and the manual stand feature mechanics were found operating according to specification. End-user was questioned as to if they had received any instruction, prior to use, covering the need to engage the safety locks which would prevent unintentional activation of stand when in the seated position. The end-user claimed having no recollection of having received that instruction, but testimony from the service provider and area sales representative differ. Based upon the lack of evidence to support a product malfunction, root cause is being considered user error. The dhr was reviewed and device met specification prior to distribution. Note: permobil had received initial report in june 2016 but was unable to determine failure mode, assignable cause or confirm the extent of injury alleged. Multiple attempts were made by permobil counsel to gather more information but went unsuccessful and the case was closed due to lack of evidence. On october 9th, 2018, permobil received information from outside counsel which provided detail into the allegations presented.
Patient Sequence No: 1, Text Type: N, H10
[126419177]
Permobil received a letter of intent claiming an incident having occurred involving a lifestand helium manual wheelchair. Letter alleged the end-user of the device was injured but did not provide any details as to what had occurred, or to the extent of the injuries sustained. Note: on 10/9/2018, permobil was made aware of serious injury from which the patient broke both femur bones and requiring surgery on both legs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221084-2018-00070 |
| MDR Report Key | 8047139 |
| Report Source | OTHER |
| Date Received | 2018-11-07 |
| Date of Report | 2018-11-07 |
| Date of Event | 2016-02-12 |
| Date Mfgr Received | 2016-06-13 |
| Device Manufacturer Date | 2014-04-28 |
| Date Added to Maude | 2018-11-07 |
| 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 | 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 | 2018-11-07 |
| 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 | 2018-11-07 |