MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-07-30 for ECHOBED DUAL 1222 manufactured by Medical Positioning, Inc..
[18303467]
On (b)(6) 2013, mpi became aware of an adverse event which took place on one of medical positioning, inc. 's (mpi) imaging tables. Below is the description from the mdr filed by (b)(6) medical center: "event description: the pt completed her echocardiogram and while sitting up she scraped the back of her right leg while preparing to move from the echo bed back to her wheel chair. Pt stated that she hit her leg. Fluid containing blood was seen dripping from her upper calf. Pt scraped the back of her leg on small 'pole holder' located on lower right half of the bed when dismounting. Pole holders have been removed from both of the echo beds. One bed has been quarantined by the department; the other is being held by quality and safety. The echo bed that was used is working properly. We have been using two echobeds in our department for several years without incident. The top and sides of the echobed are in good shape. There are no sharp edges on the lower 1/2 of the echobed. "
Patient Sequence No: 1, Text Type: D, B5
[18399839]
While the device was not directly inspected by mpi, a physical inspection was performed by (b)(6) medical center staff. The inspection found no sharp edges on the product. It was also noted that the echobed was working properly. The event could not be duplicated (a cut caused by contact with the iv pole holder). A review of the mpi complaint logs revealed that previous to this incident no one has been injured as a result of contact with the iv pole holder. The company will continue to monitor complaint and other sources of quality data for evidence of a trend; however, it appears that this is a unique incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932056-2013-00003 |
| MDR Report Key | 3608606 |
| Report Source | 99 |
| Date Received | 2013-07-30 |
| Date of Report | 2013-07-25 |
| Date of Event | 2013-07-05 |
| Date Mfgr Received | 2013-07-17 |
| Device Manufacturer Date | 2009-10-30 |
| Date Added to Maude | 2014-03-28 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOE HURTIG, MANAGER |
| Manufacturer Street | 1717 WASHINGTON ST. |
| Manufacturer City | KANSAS CITY MO 64108 |
| Manufacturer Country | US |
| Manufacturer Postal | 64108 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECHOBED DUAL |
| Generic Name | TABLE, EXAMINATION, MEDICAL, POWERED |
| Product Code | LGX |
| Date Received | 2013-07-30 |
| Model Number | 1222 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL POSITIONING, INC. |
| Manufacturer Address | KANSAS CITY MO 64108 US 64108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-07-30 |