MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-12-16 for RESPIRONICS M manufactured by Respironics.
[16827439]
Using vendor oxygen store (rotech healthcare) for cpap machine and supplies. I am now using my 5th cpap machine and supplies. I am now using my 5th cpap machine since early 2008. I have had 4 replacement machines and am hoping #5 lasts longer than the others. These machines have leaked water down my throat causing choking. Some of the other machines quit working altogether or made so much noise, i was unable to sleep! Attached is a copy of a fax i sent to my insurance provider with the dates and serial #'s of the machines. I understand that respironics was bought by philips back in the same month, before that this company was a sister company to rotech. Thank you, please contact me if more information is required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5009324 |
| MDR Report Key | 1272519 |
| Date Received | 2008-12-16 |
| Date of Report | 2008-12-15 |
| Date of Event | 2008-01-15 |
| Date Added to Maude | 2009-01-15 |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESPIRONICS |
| Generic Name | CPAP MACHINE |
| Product Code | NHJ |
| Date Received | 2008-12-16 |
| Model Number | M |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS |
| Manufacturer Address | 1001 MURRAY RIDGE LN MURRAYSVILLE PA 15668855 US 15668 8550 |
| Brand Name | RESPIRONICS |
| Generic Name | CPAP MACHINE |
| Product Code | NHJ |
| Date Received | 2008-12-16 |
| Model Number | M |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS |
| Manufacturer Address | 1001 MURRAY RIDGE LN MURRAYSVILLE PA 15668855 US 15668 8550 |
| Brand Name | RESPIRONICS |
| Generic Name | CPAP MACHINE |
| Product Code | NHJ |
| Date Received | 2008-12-16 |
| Model Number | M |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS |
| Manufacturer Address | 1001 MURRAY RIDGE LN MURRAYSVILLE PA 15668855 US 15668 8550 |
| Brand Name | RESPIRONICS |
| Generic Name | CPAP MACHINE |
| Product Code | NHJ |
| Date Received | 2008-12-16 |
| Model Number | M |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS |
| Manufacturer Address | 1001 MURRAY RIDGE LN MURRAYSVILLE PA 15668855 US 15668 8550 |
| Brand Name | RESPIRONCIS |
| Generic Name | CPAP MACHINE |
| Product Code | NHJ |
| Date Received | 2008-12-16 |
| Model Number | M |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS |
| Manufacturer Address | 1001 MURRAY RIDGE LN MURRAYSVILLE PA 15668855 US 15668 8550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-12-16 |