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 W/HUMID, DOM DSX700H11 manufactured by Respironics Inc.
[175655416]
The manufacturer became aware that a user alleges while using a bi-level continuous positive airway pressure device that he felt could he not breathe and was unable to sleep. He then went to the hospital because of this and was admitted to the icu. The user alleges that this admission was due to the bi-level continuous positive airway pressure device not functioning properly. The manufacturer's investigation us on-going. Upon completion of the investigation a follow-up report will be filed.
Patient Sequence No: 1, Text Type: D, B5
[184083714]
The manufacturer received the bi-level positive airway pressure (bipap) device and the associated heated humidifier for evaluation. The devices functioned as designed and passed all testing. After the initial report was filed, the durable medical equipment provider reported that the patient was now recanting his allegation that the device malfunctioned and caused his hospitalization. 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. " this is not a life support device. Based on the information available the manufacturer concludes that the device did not cause or contribute to the event, and no further action is necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2020-00159 |
| MDR Report Key | 9607326 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-20 |
| Date of Report | 2020-02-06 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2018-09-25 |
| 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 W/HUMID, DOM |
| Generic Name | VENTILATOR, NON-CONTINUOUS (RESPIRATOR), PRODUCT CODE: BZD |
| Product Code | BZD |
| Date Received | 2020-01-20 |
| Returned To Mfg | 2020-02-03 |
| Model Number | DSX700H11 |
| Catalog Number | DSX700H11 |
| 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 |