MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-27 for VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING manufactured by Respironics, Inc..
[181157475]
Respiratory therapist taking care of the patient received a call that they needed help in the patient's room. Respiratory therapist had a coworker covering check on the patient. The bipap mask had come apart and the patient had experienced significant desaturation into the 70's. Respiratory therapist replaced mask and increased oxygen until patient recovered. No further compromise to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9763173 |
| MDR Report Key | 9763173 |
| Date Received | 2020-02-27 |
| Date of Report | 2019-12-26 |
| Date of Event | 2019-07-16 |
| Report Date | 2020-02-21 |
| Date Reported to FDA | 2020-02-21 |
| Date Reported to Mfgr | 2020-02-27 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING |
| Product Code | MNS |
| Date Received | 2020-02-27 |
| Lot Number | AP181121 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-02-27 |