MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-07-19 for SMARTMONITOR 2 4002 manufactured by Philips Respironics - Chmv.
[3660509]
Children's medical ventures (chmv) rec'd a complaint report from a durable medical equipment (dme) supplier stating that a smart monitor device sparked, shorted out at the plug and shocked the pt. The pt was transported to the er for observation. The attending respiratory therapist was contacted for a follow-up conversation and stated that the monitor was put through the check-out procedure prior to being put into pt use. However, the outlet that the device was plugged into was not properly grounded. The pt was examined at the er and no marks where the electrodes were located were found. The pt is reportedly doing fine and no lasting impact associated with the reported event has been indicated.
Patient Sequence No: 1, Text Type: D, B5
[10960997]
(b)(4). Chmv rec'd the device for evaluation. The prongs of the power supply cable were visually inspected and found to be slightly bent with black marks at the tips. The power supply was tested and found to operate to specification. The unit was tested with the returned power supply for simulated events and no observations substantiating a malfunction or other operation outside of design specifications were made. The unit was found to operate and alarm within specifications. The smartmonitor 2 (sm2) is intended for use in continuous monitoring of hear rate and respiration of infant pts in a home. Hospital, or portable environment. Sm2 receives physiological signals via transducers attached to the pt and directly connected to the monitor, or from devices connected to the auxiliary inputs of the monitor. Physiological signals (pt events) and equipment events are recorded in nonvolatile memory for subsequent review and analysis by a health care professional. During monitoring, when the pt's breathing effort and heart activity are not within the set boundaries, an indicator light comes 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 use(s) of this equipment should not use parts have failed, exhibit excessive wear, are contaminated, or otherwise ineffective. The monitor and its accessories should not be modified. The following list incorporates 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 svc rep has certified the equipment as ready for use; the monitor and any of it 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 checkout 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. Quality assurance has determined that the complaint issue alleged by the customer was not observed during the mfr's evaluation of the product. No observations substantiating a malfunction or other operation outside of design specifications were made during the evaluation of the device. It is concluded that use of the device does not present an increased risk to the end user or pt and that no corrective action or add'l investigation activity is necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2013-00010 |
| MDR Report Key | 3249009 |
| Report Source | 99 |
| Date Received | 2013-07-19 |
| Date of Report | 2013-06-19 |
| Date Mfgr Received | 2013-06-19 |
| Date Added to Maude | 2013-07-29 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NO |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR 2 |
| Generic Name | APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2013-07-19 |
| Returned To Mfg | 2013-07-02 |
| Model Number | 4002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 1. Other | 2013-07-19 |