MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-25 for PREVALON AIRTAP PATIENT REPOSITIONING SYSTEM 7211 manufactured by Sage Products Llc.
[76014397]
Reporter did not provide involved product, photographs, or lot information. Production history records could not be reviewed. Per the instruction for use for the product, it states on page 2, "always follow your facility's safe patient handling policies and procedures". Additionally, on page 8 of the instructions for use, it states, "exterior bed rails on both surfaces should be raised prior to transfer to prevent the patient from falling. If there are no bed rails used, the caregivers are responsible for making sure the patient does not reach outside the boundaries of either support surface. " the root cause for the reported issue could not be determined. Based on the lack of information and product for evaluation, there is insufficient evidence to conclude that the reported issue was attributable to a product defect or manufacturing operations. Customer declined to release.
Patient Sequence No: 1, Text Type: N, H10
[76014398]
Report received of patient fall with possible injury while product in use. Information obtained by manufacturer sales representative, who spoke to user facility director of nursing critical care services and supervisor of radiology. The following information was provided: on (b)(6) 2017, a patient was laterally transferred from the bed to the radiology table, which has a width of twenty-four inches. Two radiology technicians assisted in the transfer. Upon laterally transferring the patient to the radiology table, the product's air-assist technology was turned off. Per the radiology technician, the product deflated unevenly resulting in the patient rolling off the radiology table and on to the floor. The initial user facility contact indicated that the patient possibly sustained a hip fracture; however, upon subsequent attempts to obtain additional information, the user facility declined to confirm report or provide clarification. Although requested, the user facility declined to provide additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419181-2017-00003 |
| MDR Report Key | 6592602 |
| Date Received | 2017-05-25 |
| Date of Report | 2017-05-25 |
| Date of Event | 2017-04-25 |
| Date Mfgr Received | 2017-04-26 |
| Date Added to Maude | 2017-05-25 |
| 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. HEATHER SIRIANNI |
| Manufacturer Street | 3909 THREE OAKS ROAD |
| Manufacturer City | CARY IL 60013 |
| Manufacturer Country | US |
| Manufacturer Postal | 60013 |
| Manufacturer Phone | 8154554700 |
| Manufacturer G1 | SAGE PRODCUTS LLC |
| Manufacturer Street | 3909 THREE OAKS ROAD |
| Manufacturer City | CARY IL 60013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PREVALON AIRTAP PATIENT REPOSITIONING SYSTEM |
| Generic Name | PATIENT REPOSITIONING SYSTEM |
| Product Code | KME |
| Date Received | 2017-05-25 |
| Model Number | 7211 |
| Catalog Number | 7211 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAGE PRODUCTS LLC |
| Manufacturer Address | 3909 THREE OAKS ROAD CARY IL 60013 US 60013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-25 |