MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,08 report with the FDA on 2012-08-08 for LEVANT BASIC manufactured by Thyssenkrupp Accessibility B.v..
[3050719]
The seat on a powered pt transport came off, causing the user to fall. The event occurred while the user was getting onto the lift and before the user was able to secure the seatbelt. The fall caused a shoulder injury for which the user later was treated in the hospital. This event occurred in (b)(6). The cause of the event was not initially discovered. After receiving additional info and doing an investigation, the manufacturer had decided to initiate a product field update.
Patient Sequence No: 1, Text Type: D, B5
[10130345]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006395295-2012-00005 |
| MDR Report Key | 2729299 |
| Report Source | 04,08 |
| Date Received | 2012-08-08 |
| Date of Report | 2011-09-01 |
| Date of Event | 2011-09-01 |
| Date Mfgr Received | 2011-09-01 |
| Date Added to Maude | 2012-09-13 |
| 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 Contact | KEVIN BRINKMAN |
| Manufacturer Street | 4001 E. 138TH ST |
| Manufacturer City | GRANDVIEW MO |
| Manufacturer Country | US |
| Manufacturer Phone | 8169654712 |
| Manufacturer G1 | THYSSENKRUPP ACCESSIBILITY B.V. |
| Manufacturer Street | VAN UTRECHTWEG 99 KRIMPEN AAN DEN IJSSEL |
| Manufacturer City | ZUID-HOLLAND 2921L |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 2921 L |
| Single Use | 0 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | 3006395295-8/7/2012-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVANT BASIC |
| Generic Name | POWERED PATIENT TRANSPORT 890.5150 |
| Product Code | ILK |
| Date Received | 2012-08-08 |
| Model Number | LEVANT |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THYSSENKRUPP ACCESSIBILITY B.V. |
| Manufacturer Address | VAN UTRECHTWEG 99 KRIMPEN AAN DEN IJSSEL ZUID-HOLLAND 2921L. NL 2921 L. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-08-08 |