MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-02-11 for RAPID RESPONSE HUT TABLE 1217 manufactured by Medical Positioning, Inc..
[21990507]
As a result of this event, medical positioning, inc. Performed an analysis of all customer-reported product event data pertaining to the rapid response hut table. The analysis indicated a repetitive issue medical positioning, inc. Has been tracking with regard to the head up tilt motor function on this product. Previous reports indicated the motor failed to operate, normally before the beginning of a procedure, with the table in a flat and level position exhibiting no potential for harm. As a result of this most recent event, it was determined that since this one occurred in a head-up position during a procedure, all customers using one of the tables manufactured in the lots we have been tracking should be notified. (b)(4). On (b)(6) 2010, medical positioning, inc. Mailed a certified letter, with return receipt requested, to each of these customers informing them we have identified a potential problem that may exist in some of the motors and advised them to "stop using the table immediately... ". In addition, medical positioning, inc. Will begin placing phone calls to each customer who has not responded to the letter on monday february 15, 2010 to confirm the info was received. To correct the problem, medical positioning inc's engineering department is working with the engineering staff of the motor mfr, skf actuation systems, to isolate and correct the issue. Once the problem is isolated and correction is thoroughly tested, the correction will be fitted on each of the tables in the list previously identified. The correction will also be part of the mfg process on all new rapid response hut tables produced.
Patient Sequence No: 1, Text Type: N, H10
[22102824]
The product involved in this event was a rapid response hut table used in electrophysiology studies. As is normal in these procedures, the pt was placed on the table and the table was tilted to 60 degree of head-up incline. Sometime after the procedure had begun the pt became unresponsive and the staff desired to return the table to a level position. To do this, a staff member pressed the head-down button on the table's hand wand control and there was no response from the table's tilt motor. The staff person then pressed the emergency head-down tilt button and again was no response from the table's tilt motor. The staff member then pressed the home button on the hand wand control (which is designed to bring the table to a level position) and there was no response from the table's tilt motor. At this point, the staff called a "code blue", and 4 additional staff members responded. The staff members safely removed the pt from the table and placed the pt on a gurney. Almost immediately upon being placed on the gurney, the pt became responsive. The hospital staff member who reported the event to medical positioning, inc. Said the pt suffered no immediate or ongoing ill effects from the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932056-2010-00001 |
| MDR Report Key | 1612347 |
| Report Source | 05,06 |
| Date Received | 2010-02-11 |
| Date of Report | 2010-02-10 |
| Date of Event | 2010-01-14 |
| Date Mfgr Received | 2010-01-14 |
| Device Manufacturer Date | 2009-07-15 |
| Date Added to Maude | 2010-10-18 |
| 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 Street | 1717 WASHINGTON |
| Manufacturer City | KANSAS CITY MO 64108 |
| Manufacturer Country | US |
| Manufacturer Postal | 64108 |
| Manufacturer Phone | 8164741555 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPID RESPONSE HUT TABLE |
| Generic Name | TILT TABLE |
| Product Code | LGX |
| Date Received | 2010-02-11 |
| Returned To Mfg | 2010-01-22 |
| Model Number | 1217 |
| 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 | 2010-02-11 |