MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-12-21 for MAXI AIR MAS000001 manufactured by Getinge Dominican Republic Sa.
[131157433]
(b)(4). Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[131157434]
Arjo was notified about 4 incidents involving arjo maxi air (air assisted patient transfer system). It was reported that patients developed rashes and blisters after laying on the maxi air for extended periods of time. Although there is no indication of serious injury, we report these incidents in abundance of caution taking into account available information such as prolong usage of device and possible serious allergic reaction. This is first out of four incidents reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681684-2018-00110 |
| MDR Report Key | 8188722 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-12-21 |
| Date of Report | 2019-01-28 |
| Date Facility Aware | 2018-11-28 |
| Report Date | 2019-01-28 |
| Date Reported to FDA | 2019-01-28 |
| Date Reported to Mfgr | 2019-01-28 |
| Date Mfgr Received | 2019-01-14 |
| Date Added to Maude | 2018-12-21 |
| 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 | PARQUE INDUSTRIAL ITABO (PIISA) BLDG 9 |
| Manufacturer City | HAINA, SAN CRIST 10903 |
| Manufacturer Country | DR |
| Manufacturer Postal | 10903 |
| Manufacturer G1 | ARJOHUNTLEIGH MAGOG INC. |
| Manufacturer Street | 2001 TANGUAY STREET |
| Manufacturer City | MAGOG, |
| Manufacturer Country | CA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXI AIR |
| Generic Name | DEVICE, TRANSFER, PATIENT, MANUAL |
| Product Code | FMR |
| Date Received | 2018-12-21 |
| Model Number | MAS000001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE DOMINICAN REPUBLIC SA |
| Manufacturer Address | PARQUE INDUSTRIAL ITABO (PIISA) BLDG 9 HAINA, SAN CRIST?BAL, 10903 DR 10903 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-21 |