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..
[2860399]
The user of a powered patient transport fell from the chair and suffered bruises when the seat broke. This event involved the same unit as a previous event. That event was not reported until this event occurred (see mfr #3006395295-2012-00003). Both events occurred in (b)(6). After receiving this report and doing an investigation, the manufacturer has decided to initiate a product field update.
Patient Sequence No: 1, Text Type: D, B5
[10169284]
.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 3006395295-2012-00004 |
MDR Report Key | 2696478 |
Report Source | 04,08 |
Date Received | 2012-08-08 |
Date of Report | 2012-04-28 |
Date of Event | 2012-04-28 |
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 |