MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-04-30 for SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODEM 4003 manufactured by Philips Medical Systems.
[20803089]
Philips healthcare received a request from the hospital for information as to whether or not it was possible to determine if the device had been shut off. The complaint stated that, when the device alarmed at 5:00am on (b)(6) 2015, the patient was checked and determined to be fine. However, when the parent checked on the patient at 7:20am, the patient was reportedly in cardiac arrest and the device was not alarming. The patient was transported to the hospital and passed away later that night.
Patient Sequence No: 1, Text Type: D, B5
[20877683]
The complaint stated that, when the device alarmed at 5:00am on (b)(4) 2015, the patient was checked and determined to be fine. However, when the parent checked on the patient at 7:20am, the patient was reportedly in cardiac arrest and the device was not alarming. The patient was transported to the hospital and passed away later that night. Per phone conversation with the hospital? S senior professional care manager, the hospital does not feel that the device malfunctioned, but they wanted to know if there was a way to tell if the device was turned off or if it shut down itself. This question was based on an initial review of a download from the device that indicted that the device was not turned on from 12:00am to 7:20am on (b)(6) 2015. The hospital and the device manufacturer reviewed the download and it showed a loose lead alarm at 12:00am. Following the loose lead alarm, the download showed that the device was manually shut off by the user and was not turned back on. Based on the available download information, the parent? S claim that the device alarmed at 5:00am cannot be confirmed. Further review of the device download showed that up until 12:00am on (b)(4) 2015, every time the device alarmed, the device was manually turned off and turned back on. The? If an alarm sounds? Section contains the following:? If an alarm sounds while you are monitoring your baby, check your baby first. Then follow the instructions below to respond to lights and alarms. Always check your baby? S skin color. Is it normal? Always check to see if your baby is breathing. If your baby is not breathing, follow the respond like this instruction.? The parents? Guide then provides a table that explains the various alarm lights, what kind of alarm it is (intermittent or continuous), a description of the patient? S condition and instructions for responding to the alarm. Under the loose leads alarm, the customer is provided with troubleshooting like checking connections and then resetting the device. There is also a note that states that? Patient alarms cannot be silenced with the reset button. The alarm will stop only when the patient signals are within the alarm limits.? Philips healthcare has received the device back for evaluation and no observations substantiating a malfunction or other operation outside of design specifications were made during the evaluation. The device was found to operate and alarm within specifications to notify a caregiver of a potential event. A 12 month complaint review has been conducted and it is concluded that this is the only complaint for this issue. Philips healthcare has determined that the complaint issue alleged by the customer was not observed during the manufacturer? S evaluation of the product. The investigation also found that the device was shut off by the user in response to an alarm condition and not turned back on afterwards. It is concluded that use of the device does not present an increased risk to the end user or patient and that no corrective action or additional investigation activity is necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2015-02335 |
| MDR Report Key | 4738914 |
| Report Source | 06 |
| Date Received | 2015-04-30 |
| Date of Report | 2015-03-31 |
| Date Mfgr Received | 2015-03-31 |
| Date Added to Maude | 2015-05-06 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MRS. WENDY CHADBOURNE |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODEM |
| Generic Name | APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2015-04-30 |
| Returned To Mfg | 2015-04-06 |
| Model Number | 4003 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-30 |