MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-16 for ECHOBED DUAL 1222 * manufactured by Medical Positioning, Inc.
[3656976]
The patient 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. Patient stated that she hit her leg. Fluid containing blood was seen dripping from her upper calf. Patient scraped back of her leg on small "pole holder" located on lower right half of echo 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 echobed 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. The echobeds have not been modified since purchase. The patient did require a procedure as a result of the injury. What was the original intended procedure? Echocardiogram. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3232378 |
| MDR Report Key | 3232378 |
| Date Received | 2013-07-16 |
| Date of Report | 2013-07-15 |
| Date of Event | 2013-07-05 |
| Report Date | 2013-07-15 |
| Date Reported to FDA | 2013-07-16 |
| Date Reported to Mfgr | 2013-07-18 |
| Date Added to Maude | 2013-07-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECHOBED DUAL |
| Generic Name | TABLE, EXAMINATION, MEDICAL, POWERED |
| Product Code | LGX |
| Date Received | 2013-07-16 |
| Model Number | 1222 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL POSITIONING, INC |
| Manufacturer Address | 1717 WASHINGTON STREET KANSAS CITY MO 64108 US 64108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-16 |