MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-31 for 16.2 PINNACLE3 SW 459801419351 manufactured by Philips Medical Systems.
[119495889]
Patient Sequence No: 1, Text Type: N, H10
[119495890]
On august 2, 2018 we received a complaint, from (b)(6) medical center, stating that the couch removal plan moves from the position selected by the user. The customer alleged this is to be a safety issue. This situation was determined to be the same as pinn00027109 (a known non-safety related defect from a complaint made by (b)(6) cancer center on (b)(6) 2017). Based on the allegation of a safety issue by uh cleveland medical center and recommendation of philips application support engineers, a special defect management committee meeting was held to discuss defect pinn00027109 (a known defect from a complaint made by (b)(6) cancer center on (b)(6) 2017). During this meeting, based on new information, from the uh cleveland medical center complaint call and investigation it was decided that the defect severity should be changed from severity 4 to severity 3. In this instance, the severity 3 is a safety-related severity 3; this is not a severity 3 due to a lack of a work-around.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004022368-2018-00003 |
| MDR Report Key | 7839397 |
| Date Received | 2018-08-31 |
| Date of Report | 2018-08-02 |
| Date Mfgr Received | 2018-08-02 |
| Date Added to Maude | 2018-08-31 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JILL KAEDER |
| Manufacturer Street | 5520 NOBEL DRIVE, SUITE 125 |
| Manufacturer City | FITCHBURG WI 53711 |
| Manufacturer Country | US |
| Manufacturer Postal | 53711 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer City | FITCHBURG WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 16.2 PINNACLE3 SW |
| Generic Name | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | MUJ |
| Date Received | 2018-08-31 |
| Model Number | 459801419351 |
| Catalog Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 5520 NOBEL DRIVE, SUITE 125 FITCHBURG WI 53711 US 53711 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-31 |