MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-17 for ISOFLEX LAL 2860 2860000000 manufactured by Stryker Medical-kalamazoo.
[89581596]
The mattress is being returned to stryker for evaluation. The customer will receive a replacement unit.
Patient Sequence No: 1, Text Type: N, H10
[89581597]
It was reported the customer developed a hospital acquired pressure injury while on the mattress.
Patient Sequence No: 1, Text Type: D, B5
[95189877]
The unit was returned to stryker. Upon return, the unit was evaluated by a stryker quality assurance engineer. No defects were found upon evaluation. Further conversation with the customer found that the patient was a (b)(6) woman who was admitted for a whipple procedure due to pancreatic adenocarcinoma. She also reportedly had diabetes which was "under control" and was a nonsmoker. The customer stated that they repositioned the patient every two hours when she allowed, however the patient did refuse repositioning at times. The customer classified the injury as a stage 2 pressure injury. The issue was resolved for the customer by stryker clinical nurse consulting discussing proper pressure injury management techniques with the customer.
Patient Sequence No: 1, Text Type: N, H10
[95189878]
It was reported the customer developed a hospital acquired pressure injury while on the mattress.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2017-00456 |
| MDR Report Key | 6956460 |
| Date Received | 2017-10-17 |
| Date of Report | 2017-12-12 |
| Date of Event | 2017-09-21 |
| Date Mfgr Received | 2017-09-21 |
| Device Manufacturer Date | 2016-01-01 |
| Date Added to Maude | 2017-10-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARY KLAVER |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693292100 |
| Manufacturer G1 | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ISOFLEX LAL 2860 |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2017-10-17 |
| Catalog Number | 2860000000 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Address | 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-17 |