MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for PASSPORT 2 MONITOR 0998-00-0900-5014A manufactured by Shenzhen Mindray Bio-medical Electronics Co., Ltd.
[185142063]
The user facility requested an evaluation of the equipment; no malfunction of the equipment was claimed. The results of the evaluation determined the monitor alarm volume was set to its minimum level. It was also observed that the heart rate numerics were displayed with a four second delay, however, high and low heart rate alarms were confirmed to have been called visually and audibly. Movement of thesis trunk cable caused ecg waveform artifact resulting in the delay of the heart rate numerics. The cable was replaced and there was no further delay with the display of heart rate numerics.
Patient Sequence No: 1, Text Type: N, H10
[185142064]
It was reported that a patient monitored on a passport 2 monitor and gas module was having surgery and one minute into the procedure the patient's heart stopped; the patient later expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2221819-2020-00005 |
| MDR Report Key | 9886495 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-21 |
| Date Facility Aware | 2020-02-28 |
| Report Date | 2020-03-26 |
| Date Reported to FDA | 2020-03-26 |
| Date Reported to Mfgr | 2020-03-26 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PASSPORT 2 MONITOR |
| Generic Name | PASSPORT 2 PATIENT MONITOR |
| Product Code | DSI |
| Date Received | 2020-03-26 |
| Catalog Number | 0998-00-0900-5014A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| Manufacturer Address | BUILDINGS 9-13 BAIWANGXIN HIGH-TECH INDUSTRIAL PARK BAIMANG, XILI TOWN, NANSHAN, SHENZEN 518108 CH 518108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-26 |