MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-02-21 for SMARTMONITOR 4003 manufactured by Phillips Respironics - Chmv.
[20856986]
Children's medical ventures (chmv) received a report from (b)(6) stating that a smartmonitor device was failing the simulator test. The smartmonitor device was reportedly not in use at the time of the reported incident.
Patient Sequence No: 1, Text Type: D, B5
[21302312]
(b)(4). The manufacturer received the device for evaluation and the customer complaint allegation was confirmed. The unit was found to alarm two to five seconds late for simulated apnea events. The recorded failure was associated with a faulty main pca. The customer refused the estimate for repair and the device was labeled as defective and returned to the customer unrepaired. No root cause analysis could be conducted. Further correspondence with the evaluating technician has concluded that the recorded failure was possibly associated with operator error. The technician did not understand the time sequencing of the testing procedure. When the device is tested, a small delay occurs between when an event begins and when the device recognizes the event. The technician has been retrained. 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. The user manual state 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 its accessories should not be modified. Based on a complete review of the available information, quality assurance has determined that no further investigation is appropriate at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2014-00006 |
| MDR Report Key | 3802342 |
| Report Source | 05 |
| Date Received | 2014-02-21 |
| Date of Report | 2014-01-23 |
| Date Mfgr Received | 2014-01-23 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2014-05-27 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR |
| Product Code | FLS |
| Date Received | 2014-02-21 |
| Returned To Mfg | 2014-01-29 |
| Model Number | 4003 |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILLIPS RESPIRONICS - CHMV |
| Manufacturer Address | 191 WYNGATE DR MONROEVILLE PA 15146 US 15146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-21 |