MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-12 for ROTH MOBELI DUAL GRIP GRAB HANDLE 14002 96 S manufactured by Roth Sanit?rprogramme Gmbh.
[75033900]
Patient Sequence No: 1, Text Type: N, H10
[75033901]
On (b)(4) 2017, the following event was reported to (b)(4) by (b)(6). (b)(6), manager of hospital equipment, sent an email to (b)(4), manager, informing him of the fall of a patient upon entrance in the eos system cabin that occurred the same day. According this preliminary information, the patient relied on two handles attached by suction cups on part of the entry; the left handle detached from its carrier, causing the patient to fall. In her message, (b)(6) joined the incident report which states the following: "? The patient, during his hospitalization, was supported as part of a full spine eos standing exam. The patient arrived on a chair but could hold the standing position. To settle in the cabin, the patient took support on the handles designed for this purpose (mobeli stabi vario reference 14002 96 s) produced by the roth company in order to go up on the machine stand. The left handle dropped suddenly during this action, causing the patient to fall. The patient fell from his height and complained of pain in his right shoulder after being helped up. The patient did not lose consciousness after falling. A radiologist has come to see the patient condition. The service in which the patient was hospitalized has been notified of the incident to observe a possible evolution of the patient's condition. The defective handle has been contained. " a site visit was made on (b)(4) 2017 by((b)(4). To assess the state of the second handle that remained in place as well as the state of the surfaces on which were attached the suction cups, and to understand the process followed by the hospital to install these handles and monitor their outfit, and get back the two handles for investigation.
Patient Sequence No: 1, Text Type: D, B5
[75756019]
This follow-up report is being submitted to reflect the device that was used (eos system) when the reported event occurred involving the roth mo beli stabi vario grab handle. The grab handle was supplied with the eos system which is manufactured by eos imaging and imported by (b)(4). The grab handle was supplied with the intention to be used with the eos system. (b)(4) has updated this report with the eos system manufacturer and importer information. The roth mobeli stabi vario grab handle is listed as a concomitant device.
Patient Sequence No: 1, Text Type: N, H10
[75756020]
Refer to initial report.
Patient Sequence No: 1, Text Type: D, B5
[113312030]
Conclusion of product analysis: the handles used by the site showed obvious signs of wear, no longer allowing safe use of these accessories on the eos system. Additionally, the handles were not used per labeled intended use (leaflet d14. 595. 12. 06) stating: "only for stabilizing the hand or arm and for fixing the hand by pressing the stabilization grip on any smooth, gastight surface: such as wash-basin, on the table of the wheelchair, desks,... Attention: don't use the grip as an aid for standing up or as a holding grip! " labeled instructions are very clear on intended use and monitoring and maintenance measures to be taken such as the safety indicator. However these instructions were provided in english and german only to the french customer, which didn't probably allow him to fully understand the intended use of the handles, monitoring and maintenance measures. On june 1, 2017, eos imaging has initiated a medical device removal of the roth mobeli grab handles used with eos system: the stabi vario model involved in the incident but also the dual grip model (model # 14002 25 s) distributed by eos imaging and that uses the same operating principle as the stabi vario handle. This field safety corrective action bears internal reference (b)(4) and has been notified to fda on may 31, 2017 ((b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[113312031]
Refer to initial report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008632827-2017-00001 |
| MDR Report Key | 6563217 |
| Date Received | 2017-05-12 |
| Date of Report | 2017-06-26 |
| Date of Event | 2017-04-14 |
| Date Facility Aware | 2017-04-14 |
| Report Date | 2017-05-12 |
| Date Reported to FDA | 2017-05-12 |
| Date Reported to Mfgr | 2017-10-05 |
| Date Added to Maude | 2017-05-12 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTH MOBELI DUAL GRIP GRAB HANDLE |
| Generic Name | MOBILITY HELPER |
| Product Code | IKX |
| Date Received | 2017-05-12 |
| Model Number | 14002 96 S |
| Catalog Number | 14002 96 S |
| Lot Number | UNKNOWN |
| Operator | RADIOLOGIC TECHNOLOGIST |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROTH SANIT?RPROGRAMME GMBH |
| Manufacturer Address | KOHLBERGSTRASSE 5 ALTENSTEIG, D-72213 GM D-72213 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-12 |