MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-07-02 for DBI (TM) TABLE 7407 manufactured by Medical Positioning, Inc..
[22508834]
Mpi worked with forbes hospital to determine the cause of the unexpected table movement. The company was able to isolate the cause to the hand control by recreating the incident at its facility. As this particular table has been in use since (b)(6) 2011, the company believes the hand control was damaged from user abuse, and has sent the hand control to the supplier, (b)(4), for further evaluation. Mpi has manufactured the dbi table since 2003 and this is the first such occurrence of this incident. The occurrence rating for this incident for the dbi tables sold since 2007 is (b)(4), or remote. If the incident were to occur again, the harm would be minor (contusion or ripping of the skin). As such, mpi has determined that no field action is necessary as this event can be prevented with user care of the hand control.
Patient Sequence No: 1, Text Type: N, H10
[22508836]
The patient was on a decubitus breast imaging (dbi) table with her left breast in compression. The table moved unexpectedly, at a normal rate of speed, approximately 9-12 inches, pulling the patient's breast out of compression. There was no death or serious injury as a result of this event, only discomfort and possibly bruising from the breast being pulled from compression. The user facility, forbes hospital, confirmed that the patient was not injured. However, medical positioning, inc. (mpi) has determined that a recurrence of the event could lead to a contusion or ripping of the skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932056-2015-00001 |
| MDR Report Key | 4898830 |
| Report Source | 05,06 |
| Date Received | 2015-07-02 |
| Date of Report | 2015-06-26 |
| Date of Event | 2015-06-08 |
| Date Mfgr Received | 2015-06-09 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2015-07-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAMERON FREEMAN |
| Manufacturer Street | 1717 WASHINGTON |
| Manufacturer City | KANSAS CITY MO 64108 |
| Manufacturer Country | US |
| Manufacturer Postal | 64108 |
| Manufacturer Phone | 8165952356 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DBI (TM) TABLE |
| Generic Name | BREAST IMAGING TABLE |
| Product Code | LGX |
| Date Received | 2015-07-02 |
| Model Number | 7407 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-07-02 |