MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-04-12 for SMART MONITOR U4003 manufactured by Childrens Medical Ventures Llc.
[3278794]
Children's medical ventures (chmv) received a customer complaint alleging a product issue of "circuit board defective, retired. " there is no allegation of pt harm and the device was not in use at the time of the reported complaint issue. During the repair eval, the unit was found to have an alarm failure. The unit was forwarded to the chmv product investigation lab for a formal investigation.
Patient Sequence No: 1, Text Type: D, B5
[10668744]
(b)(4). During the investigation, the unit was visually inspected and found to have multiple signs of physical damage associated with being dropped. The performance verification checkout procedure test found no issues with the main pca. The design incorporated visual alarm indicators were found to work to spec to alert a caregiver of a potential event. However, the sonalert alarm module was found to be inoperable due to extensive physical damage. Additionally, the units' battery enclosure was found to be damaged and the battery was found to be completely discharged rendering the unit inoperable. The unit could not be placed into service in its current condition. Smartmonitor 2 is designed to monitor and record pt's breathing (respiration), heart (cardiac) activity. The monitor alerts you if any of these activities exceeds the limits prescribed by the physician. Pt alarm limits are set by the health care professional before the smartmonitor2 is delivered to the pt. During monitoring, when the pt's breathing effort and or heart activity are not within these set boundaries, an indicator light comes on and an alarm sounds. 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 this equipment should not use parts that have failed, exhibit excessive wear, are contaminated, or otherwise ineffective. The monitor and it accessories should not be modified. The following list incorporate the owner's responsibilities: periodic check and maintenance of equipment; replacement of components as required for safe and reliable operation; replacement of ineffective parts with parts supplied by respironics, inc; equipment that is not functioning properly must not be used until all necessary maintenance has been completed and a factory authorized service rep has certified the equipment as ready for use; the monitor and any of 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 check out procedure manual #h580-4000-00 between each pt use or every 6 to 12 months or whichever is more frequent. 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 this complaint, it is concluded that the failure of the device is an isolated non systemic issue associated with excessive physical damage. The unit would not pass the performance verification checkout procedure test to be put into pt use which is the mitigation for this failure mode and is required between each pt use or every 6 to 12 months or whichever is more frequent. Qa has determined that no further investigation into the alleged complaint issue is appropriate at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2013-00005 |
| MDR Report Key | 3063561 |
| Report Source | 05 |
| Date Received | 2013-04-12 |
| Date of Report | 2013-04-09 |
| Date Mfgr Received | 2013-03-13 |
| Device Manufacturer Date | 2008-06-01 |
| Date Added to Maude | 2013-06-18 |
| 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 DRIVE |
| 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 | SMART MONITOR |
| Generic Name | APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2013-04-12 |
| Returned To Mfg | 2012-12-12 |
| Model Number | U4003 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHILDRENS MEDICAL VENTURES LLC |
| Manufacturer Address | MONROEVILLE PA 15146 US 15146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-12 |