MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-08-21 for PASSPORT 2 MONITOR manufactured by Mindray Ds Usa, Inc.
[4802608]
Customer reported an issue with the passport 2 monitor, which may have affected pt monitoring. No pt injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[12277295]
Company rep evaluated the unit. Corrections included replacement of the unit's cpu board. Unit was calibrated and safety tested to factory's specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2221819-2014-00445 |
| MDR Report Key | 4037868 |
| Report Source | 05,06,07 |
| Date Received | 2014-08-21 |
| Date of Report | 2014-06-24 |
| Date of Event | 2014-06-23 |
| Date Mfgr Received | 2014-06-24 |
| Date Added to Maude | 2014-09-05 |
| 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 | WISARA SETHACHUTKUL |
| Manufacturer Street | 800 MACARTHUR BLVD. |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2019958045 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PASSPORT 2 MONITOR |
| Generic Name | PT MONITOR |
| Product Code | BZK |
| Date Received | 2014-08-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MINDRAY DS USA, INC |
| Manufacturer Address | MAHWAH NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-21 |