MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-09-20 for SMARTMONITOR 2 4002 manufactured by Philips Respironics-chmv.
[3785499]
Children's medical ventures (chmv) received a report from a (b)(4) supplier stating that a smart monitor infant apnea monitor had failed the diagnostic test. No resulting effect on a patient or potential user has been reported. The device was reportedly not in use at the time of the reported event. However, it is not known if the device alarmed appropriately during the self-test process. The dme has been contacted for additional information and stated that they were not aware of a compliant allegation associated with the device. Additionally, the (b)(4) stated that the devices location was not currently known. No additional information is available at this time. The alleged failure is being reported due to the fact that is unknown whether or not the unit alarmed appropriately for the reported event.
Patient Sequence No: 1, Text Type: D, B5
[11213073]
(b)(4). The complaint issue alleged by the customer was not able to be confirmed because the device has not been returned to the mfr for evaluation. The purpose of the smartmonitor 2 functional self-test is to check that all the features of the unit are functioning properly. A functional self-test should be performed at least once a week or according to the instructions give by the health care professional you should also perform the test: after a lead wire is changed. After the patient cable is changed. The smartmonitor 2 (sm2) is intended for use in continuous monitoring of heart beat and respiration of infant patients in a home, hospital, or portable environment. Sm2 receives physiological signals via transducers attached to the patient and directly connected to the monitor, or from devices connected to the auxiliary inputs of the monitor. Physiological signals (patient events) and equipment event are recorded in nonvolatile memory for subsequent review and analysis by a health care professional. During monitoring, when the patient's breathing effort and heart activity are not within the set boundaries, and indicator light comes on and an alarm sounds. Patient alarm limits are set by the health care professional before the sm2 is delivered to the patient. Based on a complete review of the complaint allegation, chmv has determined that no further investigation activity into the reported issue is possible at this time. However, if the device is returned for investigation and it is concluded that a malfunction outside of the design specifications took place, a follow-up, additional information report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2013-00015 |
| MDR Report Key | 3442410 |
| Report Source | 05 |
| Date Received | 2013-09-20 |
| Date of Report | 2013-08-22 |
| Date Mfgr Received | 2013-08-22 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2014-01-03 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NO |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR 2 |
| Generic Name | APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2013-09-20 |
| Model Number | 4002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 DR MONROEVILLE PA 15146 US 15146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-20 |