MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-05 for RESPIRONICS COMFORTCLASSIC MEDIUM CPAP MASK 1007964 manufactured by Respironics.
[16464724]
Suddenly developed severe shortness of breath and chest pain on (b)(6) 2015 while using respironics comfortclassic medium cpap mask (product no. (b)(4), lot no. 140408). Evaluated in emergency room (b)(6) 2015, and found to have right lung tension pneumothorax on chest x-ray. Immediately had right sided thoracostomy with placement of chest tube under vacuum and admitted to hospital. Chest tube was removed on (b)(6) 2015 and discharged from hospital on (b)(6) 2015. After discharge from hospital, cpap mask was closely examined and was found to have an almost completely occluded exhalation port. This was confirmed by being unable to slip a piece of paper into the exhalation port. Comparison to a different, old respironics comfortclassic medium cpap mask using the same piece of paper showed that the old mask had a patent exhalation port, unlike the mask that is suspected to have caused the problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042567 |
| MDR Report Key | 4758687 |
| Date Received | 2015-05-05 |
| Date of Report | 2015-05-05 |
| Date of Event | 2015-04-25 |
| Date Added to Maude | 2015-05-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESPIRONICS COMFORTCLASSIC MEDIUM CPAP MASK |
| Generic Name | RESPIRONICS COMFORTCLASSIC MEDIUM CPAP MASK |
| Product Code | NHJ |
| Date Received | 2015-05-05 |
| Model Number | 1007964 |
| Catalog Number | 1007964 |
| Lot Number | 140408 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 2015-05-05 |