MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-10-11 for SMART MONITOR 2 PS 1014557 manufactured by Philips Respironics - Chmv.
[18361953]
Children's medical ventures (chmv) rec'd a smartmonitor 2 ps (professional series) device back from a (b)(4) supplier stating that the display was not working and that the device was alarming continuously. There is no allegation of pt harm. The device was reportedly in use at the time of the alleged failure and appropriately notified the caregiver of a potential issue.
Patient Sequence No: 1, Text Type: D, B5
[18584204]
Add'l 510(k): k061256. (b)(4). The mfr rec'd the device for eval and the complaint issue alleged by the customer was confirmed by the service technician. The unit was found to be alarming and the display's led's flashing due to the aaa batteries missing and the battery pack being depleted. An add'l finding unrelated to the customer complaint was also recorded during the eval and associated with one of the two alarms having a low audible volume. The aaa batteries and the alarm pca were replaced to correct the recorded issues. The alarm pca was forwarded to supplier quality engineering for further investigation. The primary alarm was found to operate and alarm to specification. The smartmonitor 2ps is intended for use in the continous monitoring of respiration, heart rate and spo2 levels of infant, pediatric, and adult pts. It detects and alarms for periods of high or low heart rate, high or low breath rate, and high or low saturation. When used as an infant monitor it is intended for use in a home or hospital or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environment. Based on a complete review of the available info, quality assurance has determined that none of issues recorded during the servicing of the device presents an increased risk to pt safety. However the faulty secondary alarm issue is being reported due to the critical nature of the component. The results of the investigation will be detailed in a f/u add'l info report once it has been concluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2013-00017 |
| MDR Report Key | 3458642 |
| Report Source | 00 |
| Date Received | 2013-10-11 |
| Date of Report | 2013-09-03 |
| Date Mfgr Received | 2013-09-11 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2014-01-16 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRIS FERGUSON |
| Manufacturer Street | 191 WYNGATE DR |
| Manufacturer City | MONROEVILLE PA 15146 |
| Manufacturer Country | US |
| Manufacturer Postal | 15146 |
| Manufacturer Phone | 4123808804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NO |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART MONITOR 2 PS |
| Product Code | NPF |
| Date Received | 2013-10-11 |
| Returned To Mfg | 2013-09-10 |
| Model Number | 1014557 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS RESPIRONICS - CHMV |
| Manufacturer Address | 191 WYNGATE DRIVE MONROEVILLE PA 15146 US 15146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-11 |