MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-11-02 for STRESS ECHO TABLE 2686 manufactured by Medical Positioning, Inc..
[1326898]
Upon completion of the stress echo procedure, the sonographer closed the tables drop-section (a section in the table that hinges down to provide access to the pt's chest during the echo procedure). The (b)(6) pt was left unassisted by the clinic's staff member per the clinic's own protocol for ambulatory pts and allowed to exit the table under the pt's own power. Labeling on the stress echo table clearly states not to leave pts unassisted. The pt then sat up on the table and placed her hand on the drop-section to support her weight while pushing off to stand up. As the pt was pushing off the drop-section, the drop-section opened causing the pt to lose her balance, striking her head on another piece of equipment. This incident caused a bruise on her head. The pt was given a cold pack and observed by the medical staff on-site. Later that day the pt went to the local emergency room, was examined and given a clean bill of health. This incident could not be reproduced by the staff at (b)(4). This piece of equipment was manufactured 12/30/2003 and used on a daily basis since then without any report of a similar incident occuring.
Patient Sequence No: 1, Text Type: D, B5
[8358864]
An inspection of the drop-section was completed by (b)(6) (a representative from a third party biomedical equipment maintenance company) working for (b)(4)). The inspection was performed exactly as instructed by medical positioning, inc. The inspection found the following: both drop-section latches were fully functional and operating correctly and they were within normal tolerance. The drop-section latch assembly was able to support over 200lbs of weight without failure. No physical damage found in the drop-section's mechanisms (latches, latch receiver brackets, release lever or hinge). Further investigation by medical positioning, inc. Found that the pt was left unassisted by the clinic's staff as she was exiting the table (it was found that the clinic's protocol is that if the pt is ambulatory, the staff is not to assist them when getting on and off the exam table). This protocol is incongruent with manufacturer labeling on the table which states not to leave the pt unattended. The investigation also found that table paper was in use during the exam. The inspection and further investigation confirmed that the incident was not caused by a defect in the design or manufacture of the drop-section. This unit had been in use on a daily basis for almost 6 years without similar reported incidents. The only possible conclusion which can be drawn is that the incident was due to improper use by the end user, either because the drop-section was not fully closed prior to the end of the procedure or the table paper in use at the time of the incident was allowed to interfere with the latches' ability to fully engage the receiver brackets. In either case the drop-section operated normally prior to the incident and has continued to operate normally after the incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932056-2009-00002 |
| MDR Report Key | 1521816 |
| Report Source | 05,06 |
| Date Received | 2009-11-02 |
| Date of Report | 2009-10-27 |
| Date of Event | 2009-10-12 |
| Device Manufacturer Date | 2003-12-30 |
| Date Added to Maude | 2011-03-25 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1717 WASHINGTON |
| Manufacturer City | KANSAS CITY MO 64108 |
| Manufacturer Country | US |
| Manufacturer Postal | 64108 |
| Manufacturer Phone | 8164741555 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRESS ECHO TABLE |
| Generic Name | STRESS ECHOCARDIOGRAPHY EXAM TABLE |
| Product Code | LGX |
| Date Received | 2009-11-02 |
| Model Number | 2686 |
| 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 | 1. Other | 2009-11-02 |