MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-29 for SMARTMONITOR 2 PROFESSIONAL SERIES MONITOR 1030271 manufactured by Philips Respironics - Chmv.
[3739485]
Children's medical ventures (chmv) received a report from a durable medical equipment (dme) associated with the smartmonitor 2 ps (professional series) device. The report stated that there was a long delay between patient event and the device alarming for the patient event. The smartmonitor device was reportedly in use at the time of the reported issue. No patient harm has been reported. The dme was contacted for a follow-up conversation. However, the dme was unable to provide the data download or the prescribed settings of the device in question but stated that the delay was longer than 5 seconds.
Patient Sequence No: 1, Text Type: D, B5
[11288434]
(b)(4). The complaint issue alleged by the customer was not able to be confirmed because the device was not returned to the manufacturer for evaluation. The dme stated that it could not confirm whether or not the device had been sent in for evaluation. The smartmonitor2 ps and smartmonitor2 psl are intended for use in the continuous monitoring of respiration, heart rate, and spo2 levels (smartmonitor2 ps only) of infant, pediatric, and adult patients. The device detects and alarms for periods of high or low heart rate, high or low breath rate, and high or low saturation (smartmonitor2 ps only). When used as an infant monitor, it is intended for use in a home 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. Patient alarm limits are set by the health care professional before the smartmonitor 2 ps is delivered to the patient and are typically set up with prescribed settings which include a delay before recording apneas and a delay before annunciating an alarm for an apnea condition. The user of this equipment is responsible for reading, understanding, and following the warning and caution statements throughout this manual. Based on a complete review of the complaint allegation, chmv has no reason to believe the device in question did not perform to specification; effectively notifying the caregiver of a potential event. It is determined that no further investigation into the alleged complaint issue is appropriate at this time. However, if the device is returned for investigation and it is concluded that a malfunction took place, a follow-up, additional information report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2013-00012 |
| MDR Report Key | 3358266 |
| Report Source | 05 |
| Date Received | 2013-08-29 |
| Date of Report | 2013-07-03 |
| Date Mfgr Received | 2013-07-30 |
| Device Manufacturer Date | 2009-07-01 |
| Date Added to Maude | 2013-12-02 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR 2 PROFESSIONAL SERIES MONITOR |
| Generic Name | APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2013-08-29 |
| Model Number | 1030271 |
| 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 | 2013-08-29 |