MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2013-07-15 for RAPID RESPONSE HUT TABLE 1217 manufactured by Medical Positioning, Inc..
[3610535]
The pt was undergoing a syncope test. The pt was placed into 70 degree reverse trendelenburg (head-up position) on a medical positioning, inc rapid response hut table. As symptoms of syncope presented, the nurse attempted to move the pt to a level position by pressing the emergency down button on the product's hand switch. The table did not move so the nurse pressed the head down button which didn't work either. After 1 minute, the pt was manually removed from the product and placed on the floor. The pt had lost vitals and was revived. Once stabilized, the pt was admitted into the hospital, so she could receive a pacemaker. During our investigation, the nurse stated that the table had been "temperamental" for a while, however, the customer did not report a complaint on the product until now per customer and medical positioning, inc records.
Patient Sequence No: 1, Text Type: D, B5
[10896955]
This product passed all of medical positioning's product release safety inspections and operated to spec before being packaged and shipped to the customer. Upon inspection and investigation, after the incident took place, it was found that the end user did not follow essential labeling present both on the device and in the products manual. Specifically, the end user did not follow an important electrical warning which states, "prior to connecting the product to electrical power, check to make sure the power switch located on the lower power box is in the "off" position. " inspection of the product showed that the warning label was intact and properly located on the product (attached to the power cord) and in the user instructions. While we continue to investigate the affected components, the preliminary results indicate that the act of repeatedly plugging the product into an electrical receptacle with the power switch in the "on" position may have damaged the control electronics.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932056-2013-00002 |
| MDR Report Key | 3246713 |
| Report Source | 04,05,06 |
| Date Received | 2013-07-15 |
| Date of Report | 2013-06-19 |
| Date of Event | 2013-06-18 |
| Date Mfgr Received | 2013-06-18 |
| Device Manufacturer Date | 2012-12-04 |
| Date Added to Maude | 2013-07-26 |
| 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 |
| Manufacturer Street | 1717 WASHINGTON ST |
| Manufacturer City | KANSAS CITY MO 64108 |
| Manufacturer Country | US |
| Manufacturer Postal | 64108 |
| Manufacturer Phone | 8165952356 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPID RESPONSE HUT TABLE |
| Generic Name | RAPID RESPONSE HUT TABLE |
| Product Code | LGX |
| Date Received | 2013-07-15 |
| Model Number | 1217 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL POSITIONING, INC. |
| Manufacturer Address | KANSAS CITY MO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2013-07-15 |