MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-08-26 for SMART MONITOR 2 PS 1014557 manufactured by Philips Respironics -chmv.
[5212097]
Philips healthcare received a complaint of a battery draining too quickly. The complaint issue alleged by the customer was not observed during the repair evaluation of the device at the manufacturer's service ctr, however, a finding of "faulty alarm module" not related to the customer's complaint was observed. The secondary alarm did alarm as expected but we are reporting the on the faulty alarm module preventatively. The module will be sent to the supplier and a f/u report will be filed once the investigation is complete.
Patient Sequence No: 1, Text Type: D, B5
[12639383]
(b)(4) a f/u report will be submitted once the investigation is complete. Pma 510(k): k032403, k061256.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2014-07405 |
| MDR Report Key | 4330095 |
| Report Source | 06 |
| Date Received | 2014-08-26 |
| Date of Report | 2014-08-01 |
| Date Mfgr Received | 2014-08-01 |
| Date Added to Maude | 2014-12-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NANCY ATAIDE |
| Manufacturer Street | 3000 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786597429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART MONITOR 2 PS |
| Generic Name | NPF |
| Product Code | NPF |
| Date Received | 2014-08-26 |
| Model Number | 1014557 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS RESPIRONICS -CHMV |
| Manufacturer Address | 191 WYNGATE DIVE MONROEVILLE PA 15146 US 15146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-26 |