Brand Name | REMSTAR HUMIDIFIER |
Type of Device | HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) |
Manufacturer (Section D) |
PHILIPS/ RESPIRONICS, INC. |
|
|
MDR Report Key | 18419369 |
MDR Text Key | 331638070 |
Report Number | MW5149682 |
Device Sequence Number | 1 |
Product Code |
BTT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Unknown
|
Type of Report
| Initial |
Report Date |
12/27/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/29/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Was Device Available for Evaluation? |
Yes
|
Patient Sequence Number | 1 |
Treatment | SLEEP APNEA DEVICE. |
Patient Outcome(s) |
Death;
|
Patient Age | 64 YR |
Patient Sex | Male |
Patient Weight | 113 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | White |
|
|