MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-12 for PHILIPS RESPIRONICS DREAM/WEAR UNDER THE NOSE NASAL MASK 1116707 U/K manufactured by Philips / Respironics, Inc..
[179432646]
A medical device primary package label states a size that is different from the size labeled on the actual medical device. The device is a nasal, under the nose frame for use with a cpap machine. A medium size nose frame was ordered from the supplier. On receipt of the item from the supplier, the outer label on the front of the device primary package stated "l" (large) size. Didn't open the hermetically seated package. Contacted the supplier, stated problem, supplier instructed to return item and that the item would be picked up by someone. The supplier stated will resend correct size (medium). Several days later, before anyone picked the item, the supplier called and instructed to open the hermetically sealed package and look to see if the actual item was marked medium. The item is marked "med". Supplier instructed that the item is actually a medium (the size originally ordered), to go ahead and use the item and to not return the item after all. Item is used with cpap machine for significant sleep apnea condition. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092969 |
| MDR Report Key | 9706352 |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-02-07 |
| Date Added to Maude | 2020-02-13 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| 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 |
| Brand Name | PHILIPS RESPIRONICS DREAM/WEAR UNDER THE NOSE NASAL MASK |
| Generic Name | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) |
| Product Code | BZD |
| Date Received | 2020-02-12 |
| Model Number | 1116707 |
| Catalog Number | U/K |
| Lot Number | 190708 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS / RESPIRONICS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |