MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-03-23 for SMARTMONITOR 2 WITH PCMCIA CARD SLOT 4002 manufactured by Philips Medical Systems.
[5762915]
Philips healthcare received a complaint from a durable medical equipment (dme) supplier detailing a smart monitor 2 infant apnea monitor failed to alarm for an apnea event while on a patient. It was reported that the incident occurred in (b)(6) 2014, but the device manufacturer was only notified of the incident on (b)(6) 2015. It was also reported that the patient was transported to the hospital following the incident. There is no lasting impact on the patient alleged.
Patient Sequence No: 1, Text Type: D, B5
[5846598]
Philips healthcare received a complaint from a durable medical equipment (dme) supplier detailing a smart monitor 2 infant apnea monitor failed to alarm for an apnea event while on a patient. It was reported that the incident occurred in (b)(6) of 2014, but the device manufacturer was only notified of the incident on (b)(6) 2015. It was also reported that the patient was transported to the hospital following the incident. There is no lasting impact on the patient alleged.
Patient Sequence No: 1, Text Type: D, B5
[13087271]
Based on a complete review of the complaint allegation, philips healthcare has determined that the reported issue requires further investigation. The device manufacturer is working with the dme in order to obtain the device for evaluation. Once the device evaluation is complete or additional information is received, a follow-up additional information report will be filed to detail the findings and the need for any possible further action.
Patient Sequence No: 1, Text Type: N, H10
[13474668]
The type of reported complaint has been changed from non-adverse event to serious injury because it was reported that the patient was transported to the hospital and there is no information supporting that emergent care was not required for the patient. This complaint was inadvertently not classified as a serious injury previously due to an oversight. 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. The customer stated that parents that were using the device stated that there was an apnea event that the unit did not alarm for and that the child had to be taken to the hospital. The patient has since been released from the hospital with no lasting impact. Philips healthcare has determined that the complaint issue alleged by the customer was not observed during the manufacturer? S evaluation of the product. 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. The device has been tested and returned to the customer. There have been no further related calls, suggesting the problem has not recurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2015-01623 |
| MDR Report Key | 4622795 |
| Report Source | 00 |
| Date Received | 2015-03-23 |
| Date of Report | 2015-02-26 |
| Date Mfgr Received | 2015-02-26 |
| Date Added to Maude | 2015-03-30 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 |
| Generic Name | APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2015-03-23 |
| Returned To Mfg | 2015-06-09 |
| Model Number | 4002 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | R |
| Device Age | DA |
| 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 | 2015-03-23 |