MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-09 for ECHOBED 1233 manufactured by Medical Positioning, Inc..
[15192636]
An employee of the hosp was pulling on the table when a weldment broke which caused the head end of the table to rapidly fall to the ground. While no pt was present during the incident, if a pt had been on the product when this happened, there is a possibility of serious injury.
Patient Sequence No: 1, Text Type: D, B5
[15797789]
Mpi is currently working with the customer to have the device (or at minimum the affected part(s) returned for eval. At the time of this report mpi had not received the part(s) and thus was not able to fully evaluate the device to determine whether the damage was caused by misuse or by faulty design/manufacture. Once the device is returned to mpi a full investigation will take place.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932056-2011-00006 |
| MDR Report Key | 2354841 |
| Report Source | 05,06 |
| Date Received | 2011-11-09 |
| Date of Report | 2011-11-09 |
| Date of Event | 2011-11-07 |
| Device Manufacturer Date | 2004-05-26 |
| Date Added to Maude | 2012-07-17 |
| 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 |
| Manufacturer Street | 1717 WASHINGTON |
| Manufacturer City | KANSAS CITY MO 64108 |
| Manufacturer Country | US |
| Manufacturer Postal | 64108 |
| Manufacturer Phone | 8164741555 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECHOBED |
| Generic Name | ECHOBED |
| Product Code | LGX |
| Date Received | 2011-11-09 |
| Model Number | 1233 |
| 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 | 2011-11-09 |