MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-23 for SMARTMONITOR 2 4003 manufactured by Philips Respironics - Chmv.
[15814660]
(b)(6) received a report from a durable medical equipment (dme) supplier stating that a smartmonitor 2 (sm2) infant apnea monitor alarmed too late for an apneic patient event. The event reportedly occurred (b)(6) 2013, the exact time is unknown. No specific resulting effect on the patient has been reported. The patient was reportedly transported to the hospital. The device was reportedly in use and alarmed too late. The dme has been contacted for additional patient information. However, no additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[15880806]
(b)(4). The sm2 is intended for use in continuous monitoring of heart rate and respiration of infant patients in a home, hospital, or portable environment. The sm2 device is designed to monitor respiration, and heart rate. Upon detection of abnormal events, the sm2 alerts the caregiver via both visual and audible alarms and records the information for subsequent clinical review. Patient alarm limits are set by a health care professional before the sm2 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. It is not known whether or not the device allegedly alarmed too late for the prescribed settings or if the customer felt that the prescribed settings for the apnea alarm delay were not appropriate. The device has been received by the manufacturer and is currently awaiting evaluation. The devices settings and functionality will be analyzed and the evaluation findings will be detailed in a follow-up additional information report once the investigation has been concluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2013-00020 |
| MDR Report Key | 3550448 |
| Report Source | 05 |
| Date Received | 2013-12-23 |
| Date of Report | 2013-11-25 |
| Date of Event | 2013-11-19 |
| Date Mfgr Received | 2013-11-25 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2014-01-06 |
| 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 |
| Product Code | FLS |
| Date Received | 2013-12-23 |
| Returned To Mfg | 2013-12-04 |
| Model Number | 4003 |
| Operator | OTHER |
| Device Availability | Y |
| 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 | 1. Hospitalization | 2013-12-23 |