MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-07 for CODEMASTER XL M1723A manufactured by Philips Medical Systems.
[116543096]
A follow-up report will be submitted once the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[116543097]
It was reported to philips that the device's battery alarms when turning on. There was no reported patient involvement/adverse patient impact.
Patient Sequence No: 1, Text Type: D, B5
[128466049]
The customer declined to have the device serviced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2018-06234 |
| MDR Report Key | 7759752 |
| Date Received | 2018-08-07 |
| Date of Report | 2018-07-09 |
| Date Mfgr Received | 2018-07-09 |
| Device Manufacturer Date | 2000-01-25 |
| Date Added to Maude | 2018-08-07 |
| 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 | MS. STOHN NISHINO |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Manufacturer G1 | PHILIPS HEALTHCARE - BOTHELL |
| Manufacturer Street | 22100 BOTHELL-EVERETT HWY BLDG A |
| Manufacturer City | BOTHELL WA 98021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CODEMASTER XL |
| Generic Name | DEFIB/MONITOR |
| Product Code | LDD |
| Date Received | 2018-08-07 |
| Model Number | M1723A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2018-08-07 |