MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06,07 report with the FDA on 2011-05-16 for ECHO TABLE 1283 manufactured by Medical Positioning, Inc..
[2147314]
The table was in use and neither a pt nor user-facility staff member were injured during the event, mpi feels that a recurrence of the event with a pt on the product could lead to an adverse event. A critical weld on the product was broken when weight was applied to the table by the placement of inanimate objects on the table. The weld separation caused the head end of the table to fall to the floor. If this had occurred while in use with a pt, the event could have lead to contusions and bruising from such a fall.
Patient Sequence No: 1, Text Type: D, B5
[9026339]
Upon eval it was noted that the cause of the problem was a "cold weld" which didn't penetrate properly and was able to separate when weight was applied to the product. Mpi opened (b)(4) to investigate the issue to determine the root cause for the problem, and to determine if a field correction is necessary for the issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932056-2011-00005 |
| MDR Report Key | 2108205 |
| Report Source | 04,05,06,07 |
| Date Received | 2011-05-16 |
| Date of Report | 2011-05-13 |
| Date of Event | 2011-02-25 |
| Date Mfgr Received | 2011-05-06 |
| Device Manufacturer Date | 2003-10-31 |
| Date Added to Maude | 2012-06-12 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOE HURTIG, QUALITY MGR |
| Manufacturer Street | 1717 WASHINGTON |
| Manufacturer City | KANSAS CITY MO 64108 |
| Manufacturer Country | US |
| Manufacturer Postal | 64108 |
| Manufacturer Phone | 8165952356 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECHO TABLE |
| Generic Name | ECHOCARDIOGRAPHY PROCEDURE TABLE |
| Product Code | IZZ |
| Date Received | 2011-05-16 |
| Model Number | 1283 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-05-16 |