MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-03 for XENON PULMONEX II 132 503 manufactured by Biodex Medical Systems, Inc..
[48834553]
The pulmonex xenon systems have been manufactured for more than 30 years. The materials used in the production have been basically the same for the whole time the product has been manufactured. There have been seven (7) sites that had an issue with the pulmonex - they described as a burning smell. Upon the first notification, biodex started investigating what could possibly cause this smell. There are only a few items that are a part of the system - including the disposables. Some of the disposables are supplied by biodex, but they are also supplied by other mfrs. We investigated where the different sites were getting their disposables some from biodex some from other vendors. The investigation of what is described as a burning smell by some of the sites, we contacted an environmental test lab and sent them some of the components from one of the sites. (b)(6) was advised that we were trying to find a solution and that one site that had complained of the smell when they flushed the system with oxygen, the smell went away. We were thinking that something had been introduced into the system and not part of our disposables or there had been a contaminated disposable used with the system. (b)(6) advised us that flushing with oxygen did not solve the problem. Parts were sent to the environmental test lab and that investigation is still ongoing. There is no conclusion as to what has caused the problem. The thought is that the breathing bags may be breaking down for whatever reason on a few systems. Some bags seem to be a different material. There are 30 years old units that are functioning properly. We are trying to find out if something was manufactured wrong in the bag, but that is not determined yet. Only one supplier has been used for the bags. We replaced bags and hose in the units as a temporary fix in the units that reported the problem. We are still investigating the root cause.
Patient Sequence No: 1, Text Type: N, H10
[48834554]
Title: event desc: during a lung scan, patients were complaining that the biodex pulmonex system had a strong odor and said that it was burning their lungs. Biodex was contacted on the day when the issue was first reported. The initial feedback from biodex was the system may have been contaminated so we were instructed to flush the system with oxygen. When this did not correct the problem we were told the next step would be to replace the hoses, valve, and bags. I was asked to supply the name of the vendors and the lot numbers of the chemicals being used. This info was emailed to biodex on the day after the event. On the second day after the event, i had not yet received the part numbers for the parts i was told to replace so i contacted biodex. I was now told the parts would not fix the problem and this was occurring at 10 other sites. Re (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2431314-2013-00001 |
| MDR Report Key | 5761870 |
| Date Received | 2013-07-03 |
| Date of Report | 2013-05-15 |
| Date of Event | 2013-05-06 |
| Report Date | 2013-05-01 |
| Date Reported to FDA | 2013-05-01 |
| Date Mfgr Received | 2013-06-07 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2016-06-30 |
| 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 | CLYDE SCHLEIN, VP |
| Manufacturer Street | 20 RAMSAY RD. |
| Manufacturer City | SHIRLEY NY 11967 |
| Manufacturer Country | US |
| Manufacturer Postal | 11967 |
| Manufacturer Phone | 6319249000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | XENON PULMONEX II |
| Generic Name | SYSTEM, REBREATHING, RADIONUCLIDE |
| Product Code | IYT |
| Date Received | 2013-07-03 |
| Model Number | 132 503 |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIODEX MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 20 RAMSAY RD. SHIRLEY NY 11967 US 11967 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-03 |