MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-05 for SARA PLUS HEP2001-UK manufactured by Arjohuntleigh Polska Sp. Zo.o..
[3652748]
According to the company representative description: 'the patient was being lifted into a standing position using the sara plus. Once in the standing position the patient became unsteady. He tried to step off of the foot board and then collapsed. In an attempt to release him from the sling the staff let loose the sling cords. He then slumped down catching his throat against one of the sling cords. He started to asphyxiate and the crash team was called'.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419652-2013-00175 |
| MDR Report Key | 3226023 |
| Date Received | 2013-07-05 |
| Date of Report | 2013-06-07 |
| Date of Event | 2013-06-06 |
| Date Facility Aware | 2013-06-07 |
| Report Date | 2013-07-03 |
| Date Reported to FDA | 2013-07-03 |
| Date Reported to Mfgr | 2013-07-03 |
| Date Added to Maude | 2013-07-16 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 50 NORTH GARY AVE., SUITE A |
| Manufacturer City | ROSELLE IL 601721684 |
| Manufacturer Country | US |
| Manufacturer Postal | 601721684 |
| Manufacturer G1 | ARJO, INC. |
| Manufacturer Street | 50 NORTH GARY AVE., SUITE A |
| Manufacturer City | ROSELLE IL 60172168 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60172 1684 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SARA PLUS |
| Generic Name | NONE |
| Product Code | FRW |
| Date Received | 2013-07-05 |
| Model Number | HEP2001-UK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. ZO.O. |
| Manufacturer Address | UL. KS. WAWRZYNIAKA 2 KOMORNIKI 62052 PL 62052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-07-05 |