MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-30 for PHILIPS INTEGRIS H ERROR manufactured by Philips.
[21772118]
Films from biventricular permanent pacemaker placement and ablation unable to be sent to permanent storage. Philips service rep evaluated equipment and felt reason films would not be sent was due to the case file being corrupt. Films had to be deleted from equipment. Cath lab 7.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039954 |
| MDR Report Key | 4387175 |
| Date Received | 2014-12-30 |
| Date of Report | 2014-12-29 |
| Date of Event | 2014-10-13 |
| Date Added to Maude | 2015-01-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS INTEGRIS H |
| Generic Name | XRAY SYSTEM |
| Product Code | IZF |
| Date Received | 2014-12-30 |
| Model Number | ERROR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS |
| Manufacturer Address | ANDOVER MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-30 |