MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-12 for DREAMSTATION AUTO CPAP CAX500T12 manufactured by Respironics, Inc..
[183151555]
The manufacturer became aware that a user alleges while using a continuous positive airway pressure (cpap) device , the user stated the dreamstation auto cpap was very loud and had felt it was not delivering the correct pressure. The user was unable to sleep and started having chest pains. The user went to the emergency room and had to be cardioverted to regulate his atrial fibrillation. The user has a pre-existing medical history of atrial fibrillation. Patient was discharged home the next day. There was no serious or permanent injury. The manufacturer's investigation is on-going. Upon completion of the investigation, a follow up report will be filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518422-2020-00648 |
| MDR Report Key | 9825187 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2016-09-20 |
| Date Added to Maude | 2020-03-12 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 3349303 |
| Manufacturer G1 | RESPIRONICS, INC. |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYSVILLE, PA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DREAMSTATION AUTO CPAP |
| Generic Name | VENTILATORY, NON-CONTINUOUS (RESPIRATOR) |
| Product Code | BZD |
| Date Received | 2020-03-12 |
| Model Number | CAX500T12 |
| Catalog Number | CAX500T12 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-12 |