MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-09 for SMARTMONITOR 2 4002 manufactured by Philips Respironics - Chmv.
[4462069]
Children's medical ventures (chmv) received a complaint allegation from a health care professional of a product issue associated with a smart monitor 2 device. The reported issue alleged that the device had no alarm sound. The device was reportedly in patient use at the time of the alleged failure. There is no allegation of harm associated with the reported complaint issue. The reporter of the event was contacted to verify if the smartmonitor device in question was put through the functional self-test or checkout procedure as recommended in the professional operator's manual prior to being put into patient use. The customer stated that it was unknown.
Patient Sequence No: 1, Text Type: D, B5
[12089456]
(b)(4). The complaint issue alleged by the customer was confirmed during the repair evaluation of the device at the manufacturer's service center and associated with a faulty audible alarm. When the unit turned on the alarm was found to be broken and not functioning correctly. The device could not be put through the check-out procedure to verify its performance due to its condition. The device was repaired and tested and was found to operate and alarm to specification prior to it being sent back to the customer. When the smartmonitor 2 is powered on a system check is performed. The lights on the front of the device and the alarm should both be activated briefly. The device did not complete the power up diagnostic by reporting an audible alarm tone. The smartmonitor 2 device is designed to monitor respiration and heart rate. Upon detection of abnormal events. Smartmonitor 2 alerts the caregiver via both visual and audible alarms and records the information for subsequent clinical review. 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 professional operator's manual states that the proper performance of the monitor should be verified with a respironics model 5000 simulator according to (b)(4) between each patient use or every 6 to 12 months or whichever is more frequent. Additionally, the professional operator's manual states that the a functional self-test should be performed to check that all the features of the unit are functioning properly. The functional self-test should be perform at least once a week or according to the instructions given by the health care professional. The test should also be performed after a lead wire is changed and after the patient cable is changed. The professional operator's manual also states that the monitor and accessories are designed to work as described in the operator? S manual. The user(s) of this 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. The user of this equipment is responsible for reading, understanding, an following the warning and caution statements throughout the manual. Based on a complete review of the complaint allegation, it has been concluded that the device was not functioning to specification and was not suitable for patient use. It is unknown whether or not the proper operating instructions were followed by the health care professional to verify the devices performance prior to placing it into patient use. However, based on the evaluation findings, the device would not have passed the functional self-test or the checkout procedures which are the identified mitigations for this hazard. The failure of the device has been determined to be a random malfunction that has been anticipated in the risk analysis. Risk to patients and or product users associated with the user of this product does not exceed the residual risk of using the product when it was cleared and released to the market. The identified failure is not considered to be a systemic issue. Complaint code trending will continue to be monitored on a periodic basis. Quality assurance has determined that no further investigation or action is appropriate at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2014-00013 |
| MDR Report Key | 3880559 |
| Report Source | 05 |
| Date Received | 2014-04-09 |
| Date of Report | 2013-12-23 |
| Date Mfgr Received | 2013-12-23 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2014-07-08 |
| 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 | RUSTY KELLY |
| Manufacturer Street | 12151 RESEARCH PWKY SUITE 200 |
| Manufacturer City | ORLANDO FL 32826 |
| Manufacturer Country | US |
| Manufacturer Postal | 32826 |
| Manufacturer Phone | 4074556166 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR 2 |
| Product Code | FLS |
| Date Received | 2014-04-09 |
| Returned To Mfg | 2014-01-06 |
| Model Number | 4002 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-04-09 |