MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-09-27 for ALICE 5 SYSTEM C1068726 manufactured by Respironics, Inc..
[55746463]
The manufacturer received information from a law firm that a "respironics product alice 5 psg polysomnography malfunctioned and caused burning to plaintiff's skin and permanent disfigurement to his face". There was no other information regarding the alleged injury or medical intervention required. Information received indicates the plaintiff's alleged event may have occurred at (b)(6) on approximately (b)(6) 2015. There is no indication the manufacturer was notified of this alleged event at the time. A search of the manufacturer's complaint system yielded no similar complaints. The alice 5 system is a polysomnography system that is intended to record, display,and print physiological information for clinicians or physicians. These parameters are presented graphically on a computer screen for diagnostic review similar in application to the use of a traditional paper-based polygraph recorder. The device is used in hospitals, institutions, sleep center or clinics, or other test environments where adult or infant patients require the documentation of various sleep or other physiological disorders. The alice 5 equipment collects the data from sensors placed on a patient and delivers the data to a computer running the sleepware application. The alice sleepware application is a (b)(6) based software program designed to monitor, display, process, and download polysomnographic data recorded with the alice 5 equipment. There was no serial number or material number provided for the alice 5 system. A material number is being assigned for this report, but may change if a serial number or material number are obtained and confirmed. The manufacturer's investigation is on-going. Requests have been made for additional information and the return of the device for evaluation. Upon completion of the investigation, a follow up report will be filed.
Patient Sequence No: 1, Text Type: D, B5
[61509113]
The manufacturer received information that the alice 5 polysomnography device is not implicated in the patient's alleged injury. The user facility confirmed that the device was never taken out of service, has been used on other patients since the reported event, and there have been no issues. Confirmation of the serial number was received from the user facility, therefore the material number, catalog number, and serial numbers have been updated accordingly on this report. No further action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2016-03823 |
| MDR Report Key | 5980602 |
| Report Source | OTHER |
| Date Received | 2016-09-27 |
| Date of Report | 2016-11-08 |
| Date of Event | 2015-10-13 |
| Date Mfgr Received | 2016-11-08 |
| Device Manufacturer Date | 2006-07-05 |
| Date Added to Maude | 2016-09-27 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ADAM PRICE |
| Manufacturer Street | 312 ALVIN DRIVE |
| Manufacturer City | NEW KENSINGTON PA 15068 |
| Manufacturer Country | US |
| Manufacturer Postal | 15068 |
| Manufacturer Phone | 7243349303 |
| Manufacturer G1 | RESPIRONICS, INC. |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYSVILLE PA 15668 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15668 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALICE 5 SYSTEM |
| Generic Name | ELECTROENCEPHALOGRAPH/POLYSOMNOGRAPHY SYSTEM |
| Product Code | OLZ |
| Date Received | 2016-09-27 |
| Model Number | C1068726 |
| Catalog Number | C1068726 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS, INC. |
| Manufacturer Address | 1001 MURRY RIDGE LANE MURRYSVILLE PA 15668 US 15668 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-09-27 |