MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-30 for EXHALENT 143-021D manufactured by Starion Instruments.
[1951767]
It was reported that the tip of the device came off and was retrieved. No pt info was provided.
Patient Sequence No: 1, Text Type: D, B5
[9109098]
An exhalent was returned, decontaminated and investigated. A visual inspection was performed on the returned exhalent and found that the turbinate heater was separated, confirming the complaint. The plastic insulator which holds the heater was deformed. If the heating element (tip) gets too hot and is manipulated, it may separate from the insulator which holds it. Due to the condition of the returned device, the overall performance could not be tested for abnormal activation. Individual components were evaluated for producing high tip temperatures. The returned device meets the functional requirements and is working normally. The probable cause was that the heater was not properly placed within the tissue site in accordance with the instructions for use. A review of the device history record found no issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954339-2011-00008 |
| MDR Report Key | 2068085 |
| Report Source | 06 |
| Date Received | 2011-03-30 |
| Date of Report | 2011-03-29 |
| Date of Event | 2011-02-23 |
| Date Mfgr Received | 2011-03-08 |
| Date Added to Maude | 2011-05-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DEAN CIPORKIN |
| Manufacturer Street | 1227 INNSBRUCK DRIVE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer Phone | 4085225200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXHALENT |
| Generic Name | EXHALENT |
| Product Code | HQR |
| Date Received | 2011-03-30 |
| Returned To Mfg | 2011-03-08 |
| Model Number | 143-021D |
| Catalog Number | 143-021D |
| Lot Number | 006007 |
| Device Expiration Date | 2012-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STARION INSTRUMENTS |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-30 |