MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-03 for ARISE 1000 EX LOW AIR LOSS SYSTEM AREXLAL-4888-M manufactured by Joerns Healthcare.
[174303125]
This report or other information submitted by joerns healthcare under 21 cfr part 803, and any release by fda of that report information, does not reflect a conclusion or admission by joerns healthcare, its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[174303126]
It was reported to the manufacturer by the end user, per the end user, the patient fell out of bed. The patient was transported to the local er for evaluation and sustained a bruise on the upper chest. Complaint#(b)(4) and ra#(b)(4) were entered into our system to have the mattress and control unit returned to joerns for investigation. As of this writing, the mattress and control unit have not been returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009402404-2020-00001 |
| MDR Report Key | 9548014 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-03 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2019-12-10 |
| Date Added to Maude | 2020-01-03 |
| 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 | FELICIA BANKS |
| Manufacturer Street | 2100 DESIGN ROAD |
| Manufacturer City | ARLINGTON TX 76014 |
| Manufacturer Country | US |
| Manufacturer Postal | 76014 |
| Manufacturer Phone | 8008260270 |
| Manufacturer G1 | JOERNS HEALTHCARE |
| Manufacturer Street | AVENIDA PEDRO HINOJOSA NO.26 CIUDAD INDUSTRIAL |
| Manufacturer City | MATAMOROS, TAMAULIPAS 87499 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 87499 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARISE 1000 EX LOW AIR LOSS SYSTEM |
| Generic Name | PATIENT AIR MATTRESS SYSTEM |
| Product Code | FNM |
| Date Received | 2020-01-03 |
| Model Number | AREXLAL-4888-M |
| Catalog Number | AREXLAL-4888-M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOERNS HEALTHCARE |
| Manufacturer Address | AVENIDA PEDRO HINOJOSA NO.26 CIUDAD INDUSTRIAL MATAMOROS, TAMAULIPAS 87499 MX 87499 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-03 |