MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-02-04 for SKYLIGHT IMAGING SYSTEM 2160-3001B 882420 manufactured by Philips Medical Systems (cleveland), Inc..
[1932500]
A field service engineer at the customer site has reported that the system has a crack in the detector arm. This was found during a system inspection as part of c&r activities.
Patient Sequence No: 1, Text Type: D, B5
[8956091]
Investigation by philips engineering found that three subject camera systems failed with similar modes and effects. The failure mode is the cracked lower arm casting at the upper "ear" section. This failure results in downward displacement of the arm and detector due to gravity. The exact cause of failure of this specific camera system was not determined because the arm was not made available for analysis during this period of time. No speculation is provided for cause of this failure. Additional failure analyses were conducted on two of the previously returned subject camera's arm with causes of lower arm cracks attributed to one or more of the following: material properties not meeting specification. Misalignment of the two (2) linear bearing rails and the inability of the fully compressed belleville washers to displace enough load to limit ear section bending. Operator misuse resulting in arm collision with a static object such as the patient table resulting in overloading of the lower arm casting. The amount of preload applied by the belleville washers can cause bending stresses in the ear sections. The amount of preload varies with part tolerances and bearing rail misalignment. All potentially affected skylight and precedence systems will be inspected and corrected via c&r #2916556-12/28/10-002-c. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916556-2011-00004 |
| MDR Report Key | 2013648 |
| Report Source | 06,07 |
| Date Received | 2011-02-04 |
| Date of Report | 2011-01-20 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2011-05-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH MCLAIN |
| Manufacturer Street | 5520 NOBEL DRIVE |
| Manufacturer City | FITCHBURG WI 53711 |
| Manufacturer Country | US |
| Manufacturer Postal | 53711 |
| Manufacturer Phone | 6082886948 |
| Manufacturer Street | 595 MINER RD |
| Manufacturer City | CLEVELAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44143 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2916556-12/28/10-002-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYLIGHT IMAGING SYSTEM |
| Generic Name | GAMMA CAMERA SYSTEMS |
| Product Code | IYX |
| Date Received | 2011-02-04 |
| Model Number | 2160-3001B |
| Catalog Number | 882420 |
| 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 (CLEVELAND), INC. |
| Manufacturer Address | 3860 NORTH FIRST STREET SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-04 |