MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-04-30 for RESPIRONICS #2 SMART MONITOR manufactured by Respironics.
[22101623]
In 2007, a male pt. They chose to put an apnea on him - they wanted it continued at home. This machine was totally unreliable going off when shouldn't. They stated in the paper "the chip was never on". Simply not true. Just in this town we have 20 people with the same existing problems - we've put in on the internet and you wouldn't believe the response. We are gathering much information - this agency has even ignored the coroners report of sids and even he said "these machines are unreliable". They are charging my son and daughter-in-law with neglect. Dose or amount: use as needed. Frequency: 24/7. Dates of use: 2007. Diagnosis: supposed high risk breathing problem. Second monitor the month prior. Two weeks prior, hospital has own apnea machine used till nine days later. Sent home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5011102 |
| MDR Report Key | 1386553 |
| Date Received | 2009-04-30 |
| Date of Report | 2009-04-29 |
| Date of Event | 2007-12-08 |
| Date Added to Maude | 2009-05-19 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESPIRONICS |
| Generic Name | APNEA MONITOR |
| Product Code | NPF |
| Date Received | 2009-04-30 |
| Model Number | #2 SMART MONITOR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2009-04-30 |