MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-20 for DREAMSTATION AUTO BIPAP DSX700S11 manufactured by Respironics, Inc..
[175702645]
The manufacturer became aware that a user alleges while using a bi-level continuous positive airway pressure device and heated humidifier the device shut off in the middle of the night, causing her to become short of breath and require hospitalization. The user is morbidly obese and has extensive pre-existing medical issues. The user was admitted to icu and was diagnosed with blood clots in her lungs and leg. The user was discharged home on (b)(6) 2020 and did not use the bi-level machine that night and there was no shortness of breath reported. 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
[184079625]
The manufacturer received the dreamstation auto bipap for investigation. The manufacturer does not confirm the user complaints of bipap had quit working. All patient therapy sessions were started and stopped with a manual button press. There were no logged error codes during usage dates. There were no operational issues found and the devices functioned as designed. The philips respironics dreamstation systems deliver positive airway pressure therapy for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing over 30 kg (66 lbs. ). It is for use in the home or hospital/institutional environment. The user is cautioned "contact your health care professional if symptoms of sleep apnea recur. If you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if it has been dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, disconnect the power cord and discontinue use. Contact your home care provider. " based on the information, the manufacturer is unable to confirm the complaint. No further action is necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2020-00158 |
| MDR Report Key | 9607461 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-20 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2019-01-07 |
| Date Added to Maude | 2020-01-20 |
| 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 | DREAMSTATION AUTO BIPAP |
| Generic Name | VENTILATORY, NON-CONTINUOUS (RESPIRATOR), PRODUCT CODE:BZD |
| Product Code | BZD |
| Date Received | 2020-01-20 |
| Returned To Mfg | 2020-01-22 |
| Model Number | DSX700S11 |
| Catalog Number | DSX700S11 |
| 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. Hospitalization | 2020-01-20 |