MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-07-14 for NUCLEAR IMAGING DIAGNOSTIC CAMERA TRIAD CLASSIC * manufactured by Trionix Research Lab., Inc..
[113963]
Add'l info gathered during indepth inhouse, failure mode and effect analysis.
Patient Sequence No: 1, Text Type: D, B5
[7761830]
Probability of reoccurance is low frequency of event 1 time in 10 year period, having a system with all the symptoms of this site is very slim. Through co's internal and on site investigations, co has determined that the root cause had add'l contributing factors. The following is a time line definition of the incident. - 1992 system was mfg to an inadequate assembly procedure, in that it did not specifically state to loctite the ball screw nut block assembly, thus it was at the mechanics discretion at that time to use loctite or not. - march 18, after 5 years of operation the ball screw nut became unseated from the ball screw nut block, as did the set screw. Co's field service engineer, discovered the loose assembly during a pm, he was instructed on how to repair it over the phone. - july 7, 1997 - while mapping a pt the assembly loosened a second time, becoming uncoupled from the nut block causing the detector head to fall downward toward the pt, causing an injury. - once informed trionix sent a team to the site to determine what caused the failure and what needed to be done to correctly fix it. Initial reports stated that the set screw had become unseated. - co's initial report only sited the set screw as the root cause, however upon the return of the mechanic with a full report, and the initiation of a failure mode and effect analysis, the following were also determined to be contributing factors in the failure: a. The ball screw assembly was not loctited to the nut block during initial assembly & mfr. - the assembly procedure did not direct the assembler to apply loctite to this area. - the blue print stated to loctite all hardware, thus leaving room for misinterpretation. B. The field service engineer performing the initial repair, did not realize that the ball screw was not properly seated. - there was debris left over on the shaft of the screw and in the nut block, causing the ball screw to stop prematurely, giving him the impression it was all the way on. - when he encountered resistance he assumed that it was seated as far as it would go. After his repair the system was unstable and took only three months to fail. At this time co is continuing with co's internal investigation process along with a method of preventing reoccurrence of a similar failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1527587-1997-00002 |
| MDR Report Key | 105838 |
| Report Source | 05 |
| Date Received | 1997-07-14 |
| Date of Report | 1997-07-11 |
| Date of Event | 1997-07-07 |
| Date Mfgr Received | 1997-07-07 |
| Device Manufacturer Date | 1992-03-01 |
| Date Added to Maude | 1997-07-18 |
| 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 | 0 |
| Reporter Occupation | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLEAR IMAGING DIAGNOSTIC CAMERA |
| Generic Name | GAMMA CAMERA |
| Product Code | JWM |
| Date Received | 1997-07-14 |
| Model Number | TRIAD CLASSIC |
| Catalog Number | * |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 104066 |
| Manufacturer | TRIONIX RESEARCH LAB., INC. |
| Manufacturer Address | 8037 BAVARIA RD. TWINSBURG OH 44087 US |
| Baseline Brand Name | NUCLEAR IMAGING DIAGNOSTIC CAMERA |
| Baseline Generic Name | GAMMA CAMERA |
| Baseline Model No | TRIAD CLASSIC |
| Baseline Catalog No | * |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-07-14 |