MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-09-27 for SMARTMONITOR 2 4003 manufactured by Philips Respironics - Chmv.
[3901256]
Children's medical ventures (chmv) received a report from a durable medical equipment (dme) supplier stating that a smart monitor infant apnea monitor failing to detect the patient's respiration and heart rate. No resulting effect on a patient has been reported. The device was reportedly in use at the time of the reported event. However, there is no allegation of patient harm. The dme has been contacted for additional information and stated that no additional information is available at this time. The alleged failure is being reported due to the fact that the device reportedly did not alarm during the reported event.
Patient Sequence No: 1, Text Type: D, B5
[11448468]
(b)(4). The complaint issue alleged by the customer was not able to be confirmed because the device has not been returned to the manufacturer for evaluation. The smartmonitor 2 (sm2) is intended for use in continuous monitoring of heart rate 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 events 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, an indicator light comes on and an alarm sounds. Patient alarm limits are set by the health care professional before the smartmonitor2 is delivered to the patient. The user manual states the following user/owner responsibilities. The respironics monitor and accessories are designed to work as described in the operator's manual. The user(s) of the equipment should not use parts that have failed, exhibit excessive wear, are contaminated, or otherwise ineffective. The monitor and its accessories should not be modified. As a general rule, the proper performance of the monitor should be verified with a respironics model 5000 simulator according to the checkout procedure manual #h580-4000-00 between each patient use or every 6 to 12 months or whichever is more frequent. Based on a complete review of the complaint allegation, chmv has determined that the reported issue requires further investigation. Once the device is returned for investigation, a follow-up, additional information report will be filed to detail the findings and the need for any possible further action.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2013-00016 |
| MDR Report Key | 3427557 |
| Report Source | 05 |
| Date Received | 2013-09-27 |
| Date of Report | 2013-08-30 |
| Date Mfgr Received | 2013-08-30 |
| Device Manufacturer Date | 2008-05-12 |
| Date Added to Maude | 2014-01-08 |
| 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 | SMARTMONITOR 2 |
| Generic Name | APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2013-09-27 |
| Model Number | 4003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2013-09-27 |