MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-05 for DEVILBISS 525DS manufactured by Devilbiss Healthcare.
[79117990]
(b)(4) received notice of an incident involving an oxygen concentrator that (b)(4) imports and distributes. The patient was staying in a hospice and using the oxygen concentrator when allegedly the unit failed overnight and the patient died. The unit was evaluated by (b)(4) and it was confirmed that a filter was not installed correctly leading to a malfunction and failure of the unit. This adverse event is currently under legal control.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2017-00056 |
| MDR Report Key | 6687684 |
| Date Received | 2017-07-05 |
| Date of Report | 2017-06-06 |
| Date Facility Aware | 2017-06-02 |
| Report Date | 2017-07-05 |
| Date Reported to FDA | 2017-07-05 |
| Date Reported to Mfgr | 2017-07-05 |
| Date Added to Maude | 2017-07-05 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEVILBISS |
| Generic Name | OXYGEN CONCENTRATOR |
| Product Code | NFB |
| Date Received | 2017-07-05 |
| Model Number | 525DS |
| Operator | NURSING ASSISTANT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEVILBISS HEALTHCARE |
| Manufacturer Address | 100 DEVILBISS DRIVE SOMERSET PA 15501 US 15501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-07-05 |