MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-04-16 for GEMINI DUAL PET/CT 453567900871 NA manufactured by Philips Medical Systems (cleveland), Inc..
[1048872]
Philips was informed of this event via a copy of the completed medwatch form ((b)(4)), which was submitted by the site ((b)(4)). Problem details: patient was being escorted by the technologist to the scanning area. The technologist and patient were on the same side of the patient table and were approx 18-24 inches apart. The patient table was positioned at its lowest level ( 24 inches from the floor). Patient turned to sit on the table and was asked to place her head towards the gantry. Upon attempting to get onto the table, the patient slipped off the edge, falling to the floor in an upright, sitting position. Information provided in sections 5-7 from the user facility report - no. (b)(4)). Note: per user facility (phone call (b)(6) 2008), patient died during hip replacement surgery.
Patient Sequence No: 1, Text Type: D, B5
[8327134]
Patient table has a fixed, curved edge with a slight slope to ease loading of patients from a gurney. It is designed for optimal imaging of the patient, and therefore, it is imperative that the operator remain vigilant before, during, and after the study. The gemini dual users manual, p/n 453567944211, rev. B includes the following safety statements: -"observe the following safety recommendations while performing a scanning procedure on a patient: never leave a patient unobserved before, during, or after a procedure. " -warning: make sure the patient is placed securely on the patient table and is not in danger of falling. " after investigation, it was determined that the table design is not defective and there was no table motion or system malfunction. No further action will be taken.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1525965-2008-00027 |
| MDR Report Key | 1364783 |
| Report Source | 05,06 |
| Date Received | 2009-04-16 |
| Date of Report | 2008-12-03 |
| Date of Event | 2008-10-08 |
| Date Mfgr Received | 2008-10-22 |
| Device Manufacturer Date | 2007-03-01 |
| Date Added to Maude | 2011-02-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT PHILLIPS, SR. DIR |
| Manufacturer Street | 595 MINER RD. |
| Manufacturer City | CLEVELAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal | 44143 |
| Manufacturer Phone | 4404833000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEMINI DUAL PET/CT |
| Generic Name | NUCLEAR MEDICINE EQUIPMENT |
| Product Code | IYX |
| Date Received | 2009-04-16 |
| Model Number | 453567900871 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. |
| Manufacturer Address | 595 MINER RD. CLEVELAND OH 44143 US 44143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2009-04-16 |