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 2012-03-02 for RAPID RESPONSE HUT TABLE 1217 manufactured by Medical Positioning, Inc..
[2574922]
As the nurse plugged the product into 120 vac utility power, there was a momentary spark between the outlet and the plug and the nurse received a minor shock, but no injury from the spark.
Patient Sequence No: 1, Text Type: D, B5
[9748170]
Investigation uncovered that the user was attempting to plug the product into the 120 vac utility power while the power switch is in the "on" position. Because there is a transformer in the unit, there is a momentary spike in the current draw and then levels out. The company advised the customer to make sure that the product's power switch is in the "off" position before connecting it to utility power. The company also opened capa (b)(4). Upon review of product labeling it was discovered that instructions for properly connecting the product to utility power are missing from the owner's manual. The company will update the manual with the proper instructions/warning for connecting the unit to utility power. The company will send the manual update to all nine (9) customers who have purchased the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932056-2012-00001 |
| MDR Report Key | 2507465 |
| Report Source | 04,05,06,07 |
| Date Received | 2012-03-02 |
| Date of Report | 2012-02-29 |
| Date of Event | 2012-02-28 |
| Date Mfgr Received | 2012-02-28 |
| Device Manufacturer Date | 2012-01-25 |
| Date Added to Maude | 2012-07-31 |
| 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 Contact | JOE HURTIG, QUALITY MANAGER |
| Manufacturer Street | 1717 WASHINGTON |
| Manufacturer City | KANSAS CITY MO 64108 |
| Manufacturer Country | US |
| Manufacturer Postal | 64108 |
| Manufacturer Phone | 8165952356 |
| Single Use | 3 |
| Remedial Action | RB |
| 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 | 2012-03-02 |
| Model Number | 1217 |
| Device Availability | N |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-03-02 |