MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-02-03 for REMSTAR AUTO A-FLEX, SYSTEM ONE, 60 SERIES , GB GB561S manufactured by Respironics, Inc..
[177457355]
The manufacturer received information that an end user alleged a thermal event had occurred to a power cord to a continuous positive airway pressure (cpap) device. It was not indicated where the damage had occurred, and there was no report of exposed wiring to ac components at that time. There was no harm or injury reported by the user. The manufacturer received the device and accessories for investigation and noted thermal damage to the ac inlet of the dc power supply and the ac power cord. The damage to the ac power cord connector resulted in an exposed terminal. There was no evidence of thermal damage to the cpap device. The thermal damage to the ac inlet of the dc power supply did not result in a void. The root cause of the event is most likely due to intermittent connection between the dc power supply inlet and the ac power cord. Product labeling warns the user to "periodically inspect the power for signs of wear and damage" and to "replace the power cord if necessary. " there was no harm or injury reported. This device and accessories meet all relevant standards for flammability. Based on the available information, the manufacturer concludes no further action is necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518422-2020-00232 |
| MDR Report Key | 9661392 |
| Report Source | FOREIGN |
| Date Received | 2020-02-03 |
| Date of Report | 2019-11-05 |
| Date of Event | 2019-11-05 |
| Date Mfgr Received | 2019-11-05 |
| Device Manufacturer Date | 2016-05-11 |
| Date Added to Maude | 2020-02-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | REMSTAR AUTO A-FLEX, SYSTEM ONE, 60 SERIES , GB |
| Generic Name | VENTILATOR, NON-CONTINUOUS (RESPIRATOR), PRODUCT CODE:BZD |
| Product Code | BZD |
| Date Received | 2020-02-03 |
| Returned To Mfg | 2020-01-27 |
| Model Number | GB561S |
| Catalog Number | GB561S |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 | 2020-02-03 |