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 2020-03-17 for SURESIGNS VM 4 PATIENT MONITOR 863063 manufactured by Philips Medical Systems.
[186111617]
A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[186111618]
The customer contacted the customer care solution center and alleged that the complaint device failed the audio test and was very quiet. The customer was unable to increase the volume of the complaint device. The complaint device was not in clinical use at the time that the issue was discovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2020-01745 |
| MDR Report Key | 9842567 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2010-03-11 |
| Date Added to Maude | 2020-03-17 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERT CORNING |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURESIGNS VM 4 PATIENT MONITOR |
| Generic Name | COMPACT PORTABLE PATIENT MONITORS |
| Product Code | MHX |
| Date Received | 2020-03-17 |
| Model Number | 863063 |
| Catalog Number | 863063 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-17 |