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 RAPID RESPONSE HUT TABLE 1017 manufactured by Medical Positioning, Inc..
[2004750]
During a (b)(4) study the pt's head was elevated in a steep reverse trendelenburg position when the pt's heart rate fell to 30 bpm. The staff attempted to move the table to a level position using the electric controls and the table was unresponsive. The staff manually removed the pt from the table and placed the pt flat on the floor. At that time the heart rate recovered without any cpr or other med intervention.
Patient Sequence No: 1, Text Type: D, B5
[9022747]
This device is scheduled to be evaluated by mpi once it is returned from the customer. A f/u report will be filed once eval is completed detailing the methods, results, and conclusions of the eval. This device was subject to a field correction action for a similar problem ((b)(4)). Mpi has opened a capa ((b)(4)) on the effectiveness of the field action where the investigation shows that the problem with this table is site specific and not systemic to the other tables involved in the field action. This will be tested and confirmed once the company receives the device from the facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932056-2011-00004 |
| MDR Report Key | 2108204 |
| Report Source | 04,05,06,07 |
| Date Received | 2011-05-16 |
| Date of Report | 2011-05-13 |
| Date of Event | 2011-05-06 |
| Date Mfgr Received | 2011-05-06 |
| Device Manufacturer Date | 2007-07-31 |
| Date Added to Maude | 2012-06-07 |
| 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 | JOE HURTIG, 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 |
| Removal Correction Number | Z-1973/1975-2011 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPID RESPONSE HUT TABLE |
| Generic Name | HEAD-UP TILT TABLE |
| Product Code | LGX |
| Date Received | 2011-05-16 |
| Model Number | 1017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-05-16 |