MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-12 for SPO2 SENSOR ADULT/PEDIATRIC EAR CLIP REUSABLE TRANSDUCER M1194A manufactured by Philips Medical Systems.
[120252051]
Cannot confirm serial number. A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[120252052]
The customer stated that the sp02 measurement is not correct. There was no reported patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610816-2018-00224 |
| MDR Report Key | 7869342 |
| Date Received | 2018-09-12 |
| Date of Report | 2018-09-06 |
| Date Mfgr Received | 2018-09-06 |
| Date Added to Maude | 2018-09-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERT CORNING |
| 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 | 0 |
| Brand Name | SPO2 SENSOR ADULT/PEDIATRIC EAR CLIP REUSABLE TRANSDUCER |
| Generic Name | SPO2/PLETH SENSOR |
| Product Code | BZA |
| Date Received | 2018-09-12 |
| Model Number | M1194A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-09-12 |