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..
[2860490]
The user of a powered patient transport fell from the chair and required 20-25 stitches to his face. This event was not reported at the time it happened even though the dealer was called in to do a service visit. This event was reported in conjunction with a second event involving the same unit (see mfr # 3006395295-2012-00004). Both events occurred in (b)(6). After receiving the second report and doing an investigation, the manufacturer has decided to initiate a product field update.
Patient Sequence No: 1, Text Type: D, B5
[10169279]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006395295-2012-00003 |
| MDR Report Key | 2696491 |
| Report Source | 04,08 |
| Date Received | 2012-08-08 |
| Date of Report | 2012-04-28 |
| Date of Event | 2011-08-01 |
| Date Mfgr Received | 2012-04-28 |
| Date Added to Maude | 2012-08-27 |
| 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 | 3 |
| 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 |