MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-05-29 for SMART MONITOR 2 4003 manufactured by Respironics Inc..
[1195771]
The manufacturer received a complaint alleging an apnea monitor did not annunciate an alarm during an episode of cyanosis in an infant. Reportedly, the infant was not in asystole or an apneic event when the cyanotic condition was detected by the parents; however, the parents contacted emergency medical services (ems) for assistance as a precautionary measure, ems completed the transport to the hospital without incident and the infant was discharged two days later, reportedly without further intervention. No permanent injury occurred. The manufacturer requested and received the apnea monitor for investigation. Testing of the monitor was completed using its functional self test and the manufacturer's service check out procedure (both of which are outlined in the service manual, pn1007898). The monitor performed according to design expectations without exception. The device's audible alarm output level was also measured (95. 9 db under test conditions) and found to meet the device's design specifications. The device's alarm output specification and output level both conform with the apnea monitor class ii device special controls for minimum output level for devices used in the home (75 db) and hospital (70 db) setting (fda class ii special controls guidance document: apnea monitors; guidance for industry and fda, issued july 17, 2002).
Patient Sequence No: 1, Text Type: D, B5
[8395603]
Analysis of the monitor's memory was also performed. The analysis revealed a "bradycardia" event was recorded immediately prior to the parents detecting the cyanotic condition and contacting the (b)(4) supplier and ems. The memory download revealed the bradycardia event was triggered when the infant's heart rate momentarily dropped to 69 beats per minute and violated the 70 bpm bradycardia alarm setting. The memory revealed the duration of the bradycardia alarm limit was only momentary (0. 5 seconds) and that the alarm self corrected, according to design, when the pt's heart rate increased above 70 bpm. No other pt or monitor alarms occurred after this event with the exception of the power down of the monitor prior to the transport of the infant to the hospital. The manufacturer performed an analysis of the apnea monitor's complaint and medical device report (mdr) histories to determine if the alleged failure to alarm for a cyanotic event was part of a complaint trend or had previously occurred and resulted in death or serious injury. A review of the complaint and mdr histories for the smart monitor apnea device family revealed no complaints and or medical device report submissions alleging a failure of the device to alarm for cyanosis had been recorded. The history review included complaints and mdrs reported during the previous four years, from 1/2005 to 5/1/2009. Product labeling states the intended use of the apnea monitor is to alert a caregiver to apnea, bradycardia and tachycardia events. The apnea monitor is not labeled for use in detecting or alarming for cyanosis. The parent's guide (pn 424) and the professional manual (pn 1008895) state: the smart monitor 2 may not be able to detect all episodes of inadequate breathing. The smart monitor 2 is a monitoring device only. It does not prevent the loss of breathing or heart activity. It will not prevent death. Additionally, the alarm parameters are prescribed settings that are set according to physician prescription prior to the device being used in the homecare setting. Based on information available and the findings of their investigation, the manufacturer concludes the device operated according to design specifications, did not cause or contribute to the reported event and that no further action is appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2009-00031 |
| MDR Report Key | 1400153 |
| Report Source | 04 |
| Date Received | 2009-05-29 |
| Date of Report | 2009-05-01 |
| Date of Event | 2009-04-27 |
| Date Mfgr Received | 2009-05-13 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2010-03-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHERINE DEPADUA |
| Manufacturer Street | 1740 GOLDEN MILE HIGHWAY |
| Manufacturer City | MONROEVILLE PA 15146 |
| Manufacturer Country | US |
| Manufacturer Postal | 15146 |
| Manufacturer Phone | 7243877770 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART MONITOR 2 |
| Generic Name | APNEA MONITOR |
| Product Code | NPF |
| Date Received | 2009-05-29 |
| Returned To Mfg | 2009-05-13 |
| Model Number | 4003 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-05-29 |