MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-01-26 for MP5 M8105A (865024) manufactured by Philips Medical Systems.
[98308934]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[98308935]
The customer reported that "the monitor has continued to display an ecg wave and a numeric value for the heartrate (100). But the patient was dead". The device was used for monitoring at the time of the alleged malfunction. The death of a patient was reported. No additional information regarding the patient such as gender, age, height and weight was available at the time the reporting decision was due.
Patient Sequence No: 1, Text Type: D, B5
[115695628]
The information and logs provided were forwarded to product support engineering (pse) and the clinical liaison specialist for evaluation. In general, the monitor does not generate the signal itself, it merely displays a heart rate that was also measured. Electrical activity is still present for a while after a patient's death, even if it no longer causes a pulse. The reported phenomenon was due to pulseless electrical activity (pea), which refers to cardiac arrest in which the ecg shows a heart rhythm that should produce a pulse, but does not. Under normal circumstances, electrical activation of muscle cells precedes mechanical contraction of the heart. In pea, there is electrical activity, but the heart either does not contract or there are other reasons this results in an insufficient cardiac output to generate a pulse and supply blood to the organs. Pea can be observed for up to 1 - 2 hours after the time of death. As the ecg measures the electrical activity of the heart and displays it on the monitor as a waveform and a numeric, both the ecg waveform and the heart rate numeric were still visible on the monitor after the patient passed away. The customer also requested the intellivue mp5 patient monitor to be tested in the philips bench. The bench technician found the ecg measurement to be functioning correctly during the evaluation. The reported issue could not be reproduced in the bench, even during a longer test run. Additionally, the bench technician informed the customer that the ecg trunk cable and lead set sent in with the monitor were worn and advised to order a replacement for both. The information and logs provided revealed that the reported issue was a result of pea. The customer was informed by formal letter about the results of the investigation. The product remains at the customer site. The device worked as intended and there was no malfunction of the monitor. No further investigation or action is warranted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610816-2018-00030 |
| MDR Report Key | 7221273 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-26 |
| Date of Report | 2018-01-18 |
| Date of Event | 2018-01-13 |
| Date Mfgr Received | 2018-01-18 |
| Device Manufacturer Date | 2009-08-13 |
| Date Added to Maude | 2018-01-26 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. BETTY HARRIS |
| Manufacturer Street | HEWLETT-PACKARD STR.2 |
| Manufacturer City | BOEBLINGEN 71034 |
| Manufacturer Country | GM |
| Manufacturer Postal | 71034 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MP5 |
| Generic Name | PATIENT MONITOR |
| Product Code | BZQ |
| Date Received | 2018-01-26 |
| Returned To Mfg | 2018-01-25 |
| Model Number | M8105A (865024) |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | HEWLETT-PACKARD STR.2 BOEBLINGEN 71034 GM 71034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-01-26 |