MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-17 for ALICE NIGHTONE 113277 manufactured by Respironics, Inc..
[65456808]
An end user alleged that he sustained a "chemical burn" injury while using an alice nightone portable diagnostic device during an in-home sleep study. There was no indication the user required treatment or medical intervention for the reported injury. The manufacturer requested return of the device for investigation. Upon completion of the investigation, a follow up report will be filed.
Patient Sequence No: 1, Text Type: D, B5
[72698711]
The manufacturer received the alice nightone device and aa batteries that were reportedly in use during the alleged event. There was evidence of significant battery electrolyte leakage in and around the device battery compartment. One of the batteries was leaking due to a cut in the insulation shield, and continued to leak throughout the investigation. There was no evidence of melting or warping to the alice nightone device itself. The functionality of the unit was verified with new batteries inserted, with no evidence of overheating or other issues that would cause the batteries to leak. This device meets all relevant iso and iec electrical standards. Based on the information available, the manufacturer concludes the device operated as designed, but one battery was damaged during use, causing electrolyte to come in contact with the patient's skin. Philips respironics does not manufacture or provide batteries to customers. No further action is necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2017-00105 |
| MDR Report Key | 6257741 |
| Date Received | 2017-01-17 |
| Date of Report | 2017-04-03 |
| Date of Event | 2017-01-05 |
| Date Mfgr Received | 2017-04-03 |
| Device Manufacturer Date | 2015-09-25 |
| Date Added to Maude | 2017-01-17 |
| 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 | MR. ADAM PRICE |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYSVILLE PA 15668 |
| Manufacturer Country | US |
| Manufacturer Postal | 15668 |
| 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 NIGHTONE |
| Generic Name | VENTILATORY EFFORT RECORDER |
| Product Code | MNR |
| Date Received | 2017-01-17 |
| Returned To Mfg | 2017-01-16 |
| Model Number | 113277 |
| Catalog Number | 113277 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2017-01-17 |