MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-10-05 for FLUIDAIR ELITE 300502-R manufactured by Arjohuntleigh, Inc..
[88764727]
Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4). From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted. From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4)'s complaint handling establishment and any medwatch reports will be submitted. Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[88764728]
On 10th september 2017 arjohuntleigh representative was informed about fluidair failure. It was reported that the fluid air was alarming that an overheated condition occurred and shut down the blower resulting in the surface going firm. Because the issue continued the patient was taken off of the bed and placed on a hospital bed - linet frame and arjohuntleigh mattress - first step. The nurse alleged that the bed became hard and that contributed to the failure of the patient's flap.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2017-00205 |
| MDR Report Key | 6917034 |
| Report Source | USER FACILITY |
| Date Received | 2017-10-05 |
| Date of Report | 2017-10-05 |
| Date Mfgr Received | 2017-10-09 |
| Date Added to Maude | 2017-10-05 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KINGA STOLINSKA |
| Manufacturer Street | UL. KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052, P |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052, PL |
| Manufacturer G1 | ARJOHUNTLEIGH, INC. |
| Manufacturer Street | 4958 STOUT DRIVE |
| Manufacturer City | SAN ANTONIO TX 78219 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78219 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLUIDAIR ELITE |
| Generic Name | BED, AIR FLUIDIZED |
| Product Code | INX |
| Date Received | 2017-10-05 |
| Model Number | 300502-R |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH, INC. |
| Manufacturer Address | 4958 STOUT DRIVE SAN ANTONIO TX 78219 US 78219 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-10-05 |